9 Regulatory Affairs Specialist jobs in Australia
Senior Regulatory Affairs Specialist
Macquarie Park, New South Wales
Medtronic
Posted 4 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value - and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic!
Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
The Senior Regulatory Affairs Specialist (RAS) - INTERNATIONAL will help in planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within Asia Pacific markets. This position ensures compliance with required global regulations and Medtronic policies for Diabetes products and serves as a key team member and/or in a lead role on extended team(s).
**Responsibilities may include the following and other duties may be assigned:**
+ Partner with local country RA affiliates to help planning, developing, and executing global regulatory activities necessary to obtain and maintain regulatory approvals in APAC region.
+ Interact with local RA team within APAC region and provide support needed.
+ Support and strengthen communication process between international RA and operating unit RA team.
+ Supports local RA team to prepare local submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements.
+ Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures.
+ Participate and represent OUS regulatory function in sustaining (Including MDR) and new product development projects to provide OUS regulatory requirements.
+ Assist in keeping company informed of regulatory requirements in APAC region.
+ Supports product demand planning and release activities.
+ ·Follow all assigned standard operating procedures and company policies to ensure compliance.
+ Supports all post markets regulatory requirements and audit requests.
+ Partner with local affiliates to help planning and executing license transfer and rebranding duties for the region.
+ Other duties as assigned or required.
**Required Knowledge and Experience:**
+ Bachelor's degree required with a minimum of 3-5 years of medical device regulatory affairs experience.
+ Medical Device regulatory submission/approval experience.
+ Knowledge of Asia Pacific regulations/requirements (eg TGA, PMDN, MFDS, TFDA.etc).
+ Strong Interpersonal and analytical skills.
+ Strong communication and technical writing skills.
+ Attention to detail.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value - and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic!
Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
The Senior Regulatory Affairs Specialist (RAS) - INTERNATIONAL will help in planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within Asia Pacific markets. This position ensures compliance with required global regulations and Medtronic policies for Diabetes products and serves as a key team member and/or in a lead role on extended team(s).
**Responsibilities may include the following and other duties may be assigned:**
+ Partner with local country RA affiliates to help planning, developing, and executing global regulatory activities necessary to obtain and maintain regulatory approvals in APAC region.
+ Interact with local RA team within APAC region and provide support needed.
+ Support and strengthen communication process between international RA and operating unit RA team.
+ Supports local RA team to prepare local submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements.
+ Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures.
+ Participate and represent OUS regulatory function in sustaining (Including MDR) and new product development projects to provide OUS regulatory requirements.
+ Assist in keeping company informed of regulatory requirements in APAC region.
+ Supports product demand planning and release activities.
+ ·Follow all assigned standard operating procedures and company policies to ensure compliance.
+ Supports all post markets regulatory requirements and audit requests.
+ Partner with local affiliates to help planning and executing license transfer and rebranding duties for the region.
+ Other duties as assigned or required.
**Required Knowledge and Experience:**
+ Bachelor's degree required with a minimum of 3-5 years of medical device regulatory affairs experience.
+ Medical Device regulatory submission/approval experience.
+ Knowledge of Asia Pacific regulations/requirements (eg TGA, PMDN, MFDS, TFDA.etc).
+ Strong Interpersonal and analytical skills.
+ Strong communication and technical writing skills.
+ Attention to detail.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
0
Senior Regulatory Affairs Specialist
Sydney, New South Wales
Abbott
Posted 12 days ago
Job Viewed
Job Description
**About Abbott**
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**Amazing health and wellness benefits and perks.**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.**
**Overview**
**This role is responsible for the primary responsibility of regulatory activities in Australia and New Zealand. Including managing the regulatory submissions and product updates, approving advertising materials and being responsible for regulatory and legislation changes.**
**Responsibilities**
**Manage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.**
**Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.**
**Provide assessment on product and manufacturing changes in relation to regulatory actions.**
**Review and approving promotional material for compliance with relevant regulations and codes.**
**Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholders**
**Provide training and guidance on Regulatory topics to stakeholders where applicable.**
**Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.**
**You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.**
**Qualifications and Experience**
**Essential**
**Science Degree or equivalent**
**Minimum 7 years Regulatory experience within the medical devices or IVD industry.**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**Amazing health and wellness benefits and perks.**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.**
**Overview**
**This role is responsible for the primary responsibility of regulatory activities in Australia and New Zealand. Including managing the regulatory submissions and product updates, approving advertising materials and being responsible for regulatory and legislation changes.**
**Responsibilities**
**Manage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.**
**Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.**
**Provide assessment on product and manufacturing changes in relation to regulatory actions.**
**Review and approving promotional material for compliance with relevant regulations and codes.**
**Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholders**
**Provide training and guidance on Regulatory topics to stakeholders where applicable.**
**Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.**
**You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.**
**Qualifications and Experience**
**Essential**
**Science Degree or equivalent**
**Minimum 7 years Regulatory experience within the medical devices or IVD industry.**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
1
ANZ Regulatory Affairs Lead Specialist
Mascot, New South Wales
GE HealthCare
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, pre-market submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.
This position is a 12 month maternity leave contract.
**Job Description**
**Roles and Responsibilities**
+ Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
+ Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
+ Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
+ Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
+ Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
**Required Qualifications**
+ This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
**Desired Characteristics**
+ Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
**Additional Information**
**Relocation Assistance Provided:** No
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, pre-market submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.
This position is a 12 month maternity leave contract.
**Job Description**
**Roles and Responsibilities**
+ Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
+ Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
+ Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
+ Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
+ Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
**Required Qualifications**
+ This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
**Desired Characteristics**
+ Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Affairs Manager
North Ryde, New South Wales
Lundbeck
Posted 5 days ago
Job Viewed
Job Description
Regulatory Affairs Manager
Requistion ID: 6850
Location:
North Ryde, New South Wales, AU
Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product portfolio. This role is critical in ensuring compliance with local regulatory requirements for Lundbeck's products, overseeing regulatory submissions, maintaining licences and liaising with government authorities. The Regulatory Affairs Manager plays a critical part in ensuring product approval, lifecycle management and alignment with industry standards while supporting the business strategic objectives. Reporting to the Medical Director, we are looking for an individual with a passion for the CNS and neurology therapy areas.
**Your new role**
In your new role, your areas of focus:
- Prepare, review, and submit regulatory applications and dossiers to health authorities (TGA, Medsafe, PBAC, PHARMAC).
- Monitor marketing application progress and maintain licenses for imported goods.
- Analyse scientific content of registration packages to ensure regulatory compliance.
- Liaise with government departments and consultants to facilitate product approvals and reformulations.
- Negotiate with regulatory bodies on product information, storage, shipment, and quality standards.
- Respond to investigations and queries related to product integrity, packaging, and storage.
- Review and approve promotional materials in line with Medicines Australia's Code of Conduct.
- Support phase 3 clinical trials by managing CTNs and liaising with the TGA and CROs.
- Lead internal audits and represent the affiliate in global QA forums.
- Maintain SOPs, Crisis Management documentation, and Risk Management Plans.
- Provide training to new employees on regulatory processes and requirements.
- Monitor regulatory changes and assess business impact.
**Your future team**
You will be part of a passionate and purpose-driven medical team committed to excellence and innovation in the pharmaceutical industry. You'll be able to contribute to an expanding portfolio with a forward-looking focus on neuro rare disease breakthroughs. The teams collaborative culture fosters creativity, professional growth, and cross-functional synergy across the organisation. Lundbeck Australia's local headquarters is proudly located in North Ryde, Sydney.
**What you bring to the team**
The ideal candidate will possess:
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or Regulatory Affairs (Master's preferred).
- 3-5 years' experience in Regulatory Affairs within the pharmaceutical, biotech, or healthcare industry.
- Strong understanding of Australian and New Zealand regulatory environments.
- Proven success in regulatory submissions and product approvals (Category 1 and 2).
- Strategic thinker with excellent analytical, negotiation, and communication skills.
- Experience in neuro rare or rare disease regulatory submissions is highly desirable but not ssential.
**Our promise to you**
Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.
We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at .
**Apply now**
Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you're not sure if you meet all the requirements? We still want to hear from you!
Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
Requistion ID: 6850
Location:
North Ryde, New South Wales, AU
Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product portfolio. This role is critical in ensuring compliance with local regulatory requirements for Lundbeck's products, overseeing regulatory submissions, maintaining licences and liaising with government authorities. The Regulatory Affairs Manager plays a critical part in ensuring product approval, lifecycle management and alignment with industry standards while supporting the business strategic objectives. Reporting to the Medical Director, we are looking for an individual with a passion for the CNS and neurology therapy areas.
**Your new role**
In your new role, your areas of focus:
- Prepare, review, and submit regulatory applications and dossiers to health authorities (TGA, Medsafe, PBAC, PHARMAC).
- Monitor marketing application progress and maintain licenses for imported goods.
- Analyse scientific content of registration packages to ensure regulatory compliance.
- Liaise with government departments and consultants to facilitate product approvals and reformulations.
- Negotiate with regulatory bodies on product information, storage, shipment, and quality standards.
- Respond to investigations and queries related to product integrity, packaging, and storage.
- Review and approve promotional materials in line with Medicines Australia's Code of Conduct.
- Support phase 3 clinical trials by managing CTNs and liaising with the TGA and CROs.
- Lead internal audits and represent the affiliate in global QA forums.
- Maintain SOPs, Crisis Management documentation, and Risk Management Plans.
- Provide training to new employees on regulatory processes and requirements.
- Monitor regulatory changes and assess business impact.
**Your future team**
You will be part of a passionate and purpose-driven medical team committed to excellence and innovation in the pharmaceutical industry. You'll be able to contribute to an expanding portfolio with a forward-looking focus on neuro rare disease breakthroughs. The teams collaborative culture fosters creativity, professional growth, and cross-functional synergy across the organisation. Lundbeck Australia's local headquarters is proudly located in North Ryde, Sydney.
**What you bring to the team**
The ideal candidate will possess:
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or Regulatory Affairs (Master's preferred).
- 3-5 years' experience in Regulatory Affairs within the pharmaceutical, biotech, or healthcare industry.
- Strong understanding of Australian and New Zealand regulatory environments.
- Proven success in regulatory submissions and product approvals (Category 1 and 2).
- Strategic thinker with excellent analytical, negotiation, and communication skills.
- Experience in neuro rare or rare disease regulatory submissions is highly desirable but not ssential.
**Our promise to you**
Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.
We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at .
**Apply now**
Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you're not sure if you meet all the requirements? We still want to hear from you!
Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Lead
St Leonards, New South Wales
Stryker
Posted 9 days ago
Job Viewed
Job Description
**About the role:**
The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities for Stryker South Pacific, ensuring compliance with relevant regulations and legislation.
This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation for complex regulatory matters. Additionally, the Regulatory Affairs Lead will coach and mentor team members, providing guidance to support their professional development.
**About you:**
You're a sharp, commercially minded professional with experience navigating complex, highly regulated environments - whether that's FMCG, Alcohol, Financial Services, Pharma, Life Sciences, or similar. You may not come from a traditional Regulatory Affairs or medical device background, and that's okay. What matters is your ability to think strategically, influence stakeholders, and solve problems with confidence and care.
You're ready to step into a role that blends compliance with commercial impact. You're a natural relationship builder, a persuasive communicator, and a curious learner who thrives in complex, fast-paced environments. You may not have led a team yet, but you're hungry to grow into leadership-and we're ready to support that journey.
**Key responsibilities**
+ **Strategic regulatory guidance:** Advise on product registration pathways, regulatory strategies, and business acquisitions to accelerate speed to market and align with commercial goals;
+ **Risk management and compliance:** Identify and mitigate regulatory risks while ensuring compliance with legislation, standards, and internal procedures. Support post-market activities and change management initiatives;
+ **Process improvement and implementation:** Lead the rollout of new regulatory processes and contribute to continuous improvement efforts that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** Act as a trusted escalation point for complex regulatory issues. Collaborate cross-functionally to resolve challenges and deliver strategic solutions **;** and
+ **Leadership and team development:** Coach and support peers and junior team members, building technical capability and fostering a culture of growth and learning.
**Must have experience/skills:**
We're looking for someone with a unique blend of skills and mindset. You'll thrive here if you have:
+ Exposure to highly regulated industries and a strong understanding of compliance frameworks;
+ Tertiary qualifications in a related discipline;
+ Excellent communication, negotiation, and influencing skills;
+ A strategic mindset with the ability to balance detail and big-picture thinking;
+ A collaborative style and the ability to navigate competing priorities;
+ A passion for continuous improvement and smarter ways of working; and
+ An interest in coaching, mentoring and developing teams with a desire to grow into leadership in future.
**Desired but not essential experience/skills:**
If you've got any of the following, that's a plus-but not a dealbreaker:
+ Experience in medical device regulatory affairs (Australia, NZ, FDA, EU MDR);
+ Familiarity with Prostheses List management; and
+ Prior team management or mentoring experience.
**To join us, click apply now!**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities for Stryker South Pacific, ensuring compliance with relevant regulations and legislation.
This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation for complex regulatory matters. Additionally, the Regulatory Affairs Lead will coach and mentor team members, providing guidance to support their professional development.
**About you:**
You're a sharp, commercially minded professional with experience navigating complex, highly regulated environments - whether that's FMCG, Alcohol, Financial Services, Pharma, Life Sciences, or similar. You may not come from a traditional Regulatory Affairs or medical device background, and that's okay. What matters is your ability to think strategically, influence stakeholders, and solve problems with confidence and care.
You're ready to step into a role that blends compliance with commercial impact. You're a natural relationship builder, a persuasive communicator, and a curious learner who thrives in complex, fast-paced environments. You may not have led a team yet, but you're hungry to grow into leadership-and we're ready to support that journey.
**Key responsibilities**
+ **Strategic regulatory guidance:** Advise on product registration pathways, regulatory strategies, and business acquisitions to accelerate speed to market and align with commercial goals;
+ **Risk management and compliance:** Identify and mitigate regulatory risks while ensuring compliance with legislation, standards, and internal procedures. Support post-market activities and change management initiatives;
+ **Process improvement and implementation:** Lead the rollout of new regulatory processes and contribute to continuous improvement efforts that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** Act as a trusted escalation point for complex regulatory issues. Collaborate cross-functionally to resolve challenges and deliver strategic solutions **;** and
+ **Leadership and team development:** Coach and support peers and junior team members, building technical capability and fostering a culture of growth and learning.
**Must have experience/skills:**
We're looking for someone with a unique blend of skills and mindset. You'll thrive here if you have:
+ Exposure to highly regulated industries and a strong understanding of compliance frameworks;
+ Tertiary qualifications in a related discipline;
+ Excellent communication, negotiation, and influencing skills;
+ A strategic mindset with the ability to balance detail and big-picture thinking;
+ A collaborative style and the ability to navigate competing priorities;
+ A passion for continuous improvement and smarter ways of working; and
+ An interest in coaching, mentoring and developing teams with a desire to grow into leadership in future.
**Desired but not essential experience/skills:**
If you've got any of the following, that's a plus-but not a dealbreaker:
+ Experience in medical device regulatory affairs (Australia, NZ, FDA, EU MDR);
+ Familiarity with Prostheses List management; and
+ Prior team management or mentoring experience.
**To join us, click apply now!**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Associate
Sydney, New South Wales
Abbott
Posted 12 days ago
Job Viewed
Job Description
**About Abbott**
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.**
**An exciting 2-year fixed term contract opportunity has come up which is ideal for candidate with foundational experience in Regulatory Affairs for Medical devices/In Vitro Diagnostics. We are looking for an extremely motivated Regulatory Affairs Associate to support On-market activities. This is cross divisional role with primary functions within Diagnostics Division. This role will provide a wide range of support activities across the Regulatory Department and will be ideal for a proactive and resilient self-starter, with excellent multi-tasking abilities and a high attention to detail. Based at our head office in Macquarie Park, this role would require you to work with a close-knit team that's consistently working towards providing insights that enable smarter, faster decisions to transform the way the world is managing health.**
**The main aspects of this role include:**
**Collaborate with cross-functional teams-including marketing, sales, and logistics-to develop regulatory strategies that support on market products**
**Prepare and lodge regulatory submissions, including those requiring conformity assessments, for changes to on market in vitro diagnostic (IVD) products and updates to internal compliance records**
**Review and evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards before forwarding to the appropriate national authority.**
**Advise global regulatory on** **-** **market teams on local compliance needs to support innovation product maintenance requirements and/or modifications.**
**Partner with marketing to review and approve promotional content, ensuring adherence to local advertising regulations.**
**Offer mentorship, training, and support to regulatory affairs (RA) colleagues, while leveraging data to identify and implement process improvements.**
**Maintain a thorough understanding of ISO 9001, the Therapeutic Goods Act 1989, and the Australian Medical Devices Regulations 2002, along with other applicable federal and state laws.**
**Monitor and assess changes to emerging regulations for on market products and communicate potential impacts to both local and global teams.**
**Drive process updates in response to such changes, collaborating with Quality Assurance to ensure integration into the quality management system.**
**Secure additional regulatory authorisations as needed, such as import permits and Certificates of Free Sale (CFS).**
**Stay informed on global regulatory developments, guidance updates, and industry best practices.**
**Provide timely regulatory intelligence and updates to leadership and cross-functional teams.**
**Maintain regulatory documentation and records in accordance with internal procedures and regulatory requirements.**
**Ensure all regulatory decisions and activities are accurately documented.**
**Prepare regulatory reports and summaries for internal and external stakeholders.**
**Participate in cross-functional projects to meet regulatory and quality goals.**
**Promote a collaborative team culture that values open communication, diversity and shared learning.**
**What would make you a successful candidate**
**A degree in science, biomedical studies, or a related field.**
**At least 2-3 years of experience in regulatory affairs within the medical device or IVD sector.**
**Solid understanding of both Australian and international regulatory frameworks (e.g., TGA, FDA, EU IVDR).**
**Familiarity with ISO 13485 and other relevant quality standards.**
**Exceptional verbal, written, and interpersonal communication skills are essential for this role, as it requires frequent engagement with internal and external stakeholders, clear articulation of complex regulatory concepts, and the ability to build strong collaborative relationships across diverse teams.**
**Ability to work autonomously and collaboratively in a dynamic environment.**
**Exceptional attention to detail across all regulatory and quality tasks.**
**A mindset geared toward innovation and continuous improvement.**
**Proactive engagement with industry trends and regulatory updates.**
**Proven ability to manage multiple projects and competing priorities.**
**Proficiency in Microsoft Office and other standard business applications**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.**
**An exciting 2-year fixed term contract opportunity has come up which is ideal for candidate with foundational experience in Regulatory Affairs for Medical devices/In Vitro Diagnostics. We are looking for an extremely motivated Regulatory Affairs Associate to support On-market activities. This is cross divisional role with primary functions within Diagnostics Division. This role will provide a wide range of support activities across the Regulatory Department and will be ideal for a proactive and resilient self-starter, with excellent multi-tasking abilities and a high attention to detail. Based at our head office in Macquarie Park, this role would require you to work with a close-knit team that's consistently working towards providing insights that enable smarter, faster decisions to transform the way the world is managing health.**
**The main aspects of this role include:**
**Collaborate with cross-functional teams-including marketing, sales, and logistics-to develop regulatory strategies that support on market products**
**Prepare and lodge regulatory submissions, including those requiring conformity assessments, for changes to on market in vitro diagnostic (IVD) products and updates to internal compliance records**
**Review and evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards before forwarding to the appropriate national authority.**
**Advise global regulatory on** **-** **market teams on local compliance needs to support innovation product maintenance requirements and/or modifications.**
**Partner with marketing to review and approve promotional content, ensuring adherence to local advertising regulations.**
**Offer mentorship, training, and support to regulatory affairs (RA) colleagues, while leveraging data to identify and implement process improvements.**
**Maintain a thorough understanding of ISO 9001, the Therapeutic Goods Act 1989, and the Australian Medical Devices Regulations 2002, along with other applicable federal and state laws.**
**Monitor and assess changes to emerging regulations for on market products and communicate potential impacts to both local and global teams.**
**Drive process updates in response to such changes, collaborating with Quality Assurance to ensure integration into the quality management system.**
**Secure additional regulatory authorisations as needed, such as import permits and Certificates of Free Sale (CFS).**
**Stay informed on global regulatory developments, guidance updates, and industry best practices.**
**Provide timely regulatory intelligence and updates to leadership and cross-functional teams.**
**Maintain regulatory documentation and records in accordance with internal procedures and regulatory requirements.**
**Ensure all regulatory decisions and activities are accurately documented.**
**Prepare regulatory reports and summaries for internal and external stakeholders.**
**Participate in cross-functional projects to meet regulatory and quality goals.**
**Promote a collaborative team culture that values open communication, diversity and shared learning.**
**What would make you a successful candidate**
**A degree in science, biomedical studies, or a related field.**
**At least 2-3 years of experience in regulatory affairs within the medical device or IVD sector.**
**Solid understanding of both Australian and international regulatory frameworks (e.g., TGA, FDA, EU IVDR).**
**Familiarity with ISO 13485 and other relevant quality standards.**
**Exceptional verbal, written, and interpersonal communication skills are essential for this role, as it requires frequent engagement with internal and external stakeholders, clear articulation of complex regulatory concepts, and the ability to build strong collaborative relationships across diverse teams.**
**Ability to work autonomously and collaboratively in a dynamic environment.**
**Exceptional attention to detail across all regulatory and quality tasks.**
**A mindset geared toward innovation and continuous improvement.**
**Proactive engagement with industry trends and regulatory updates.**
**Proven ability to manage multiple projects and competing priorities.**
**Proficiency in Microsoft Office and other standard business applications**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
5
Regulatory Affairs Associate
Macquarie Park, New South Wales
Sanofi Group
Posted 12 days ago
Job Viewed
Job Description
**_Regulatory Affairs Associate_**
+ **Location - Macquarie Park, Sydney**
+ **Permanent full-time position**
**About the role**
As a Regulatory Affairs Associate within our Regulatory Affairs team, you'll play a key role in supporting regulatory submissions and strategic projects across Sanofi's diverse portfolio. Based in Macquarie Park, you'll join a close-knit, high-performing team that values collaboration, execution, and growth.
**About Sanofi**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main responsibilities**
+ Support regulatory submissions related to clinical trials, GMP, medicine shortages, and medical devices
+ Assist with data entry, documentation, and administrative tasks
+ Collaborate with internal stakeholders and external vendors to ensure compliance and timely delivery
+ Maintain regulatory databases and contribute to audit readiness
+ Participate in strategic projects and transversal initiatives
+ Build strong relationships with health authorities and regulatory bodies
+ Contribute to continuous improvement of regulatory systems and processes
**About you**
**You have exposure to regulatory affairs, clinical trials, or GMP within the pharmaceutical or biotech industry, and thrive in collaborative, fast-paced environments. You bring strong attention to detail and a focus on execution, along with excellent communication and teamwork skills. Technically, you're proficient in MS Office and database systems, and have a natural inclination toward digital and AI-driven tools.**
**Why choose us?**
+ Be part of a pioneering biopharma company where patient insights shape drug development
+ Work at the forefront of AI-powered science that accelerates discovery and improves outcomes
+ Explore bold career paths - with opportunities to grow through scientific, leadership, and cross-functional moves
+ Care for yourself and your loved ones with generous health and well-being benefits, including top-tier healthcare and 14 weeks' gender-neutral parental leave
+ Join a close-knit, ambitious team with a track record of internal growth and global career progression
+ Gain exposure to strategic projects and transversal regulatory initiatives
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary - together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
+ **Location - Macquarie Park, Sydney**
+ **Permanent full-time position**
**About the role**
As a Regulatory Affairs Associate within our Regulatory Affairs team, you'll play a key role in supporting regulatory submissions and strategic projects across Sanofi's diverse portfolio. Based in Macquarie Park, you'll join a close-knit, high-performing team that values collaboration, execution, and growth.
**About Sanofi**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main responsibilities**
+ Support regulatory submissions related to clinical trials, GMP, medicine shortages, and medical devices
+ Assist with data entry, documentation, and administrative tasks
+ Collaborate with internal stakeholders and external vendors to ensure compliance and timely delivery
+ Maintain regulatory databases and contribute to audit readiness
+ Participate in strategic projects and transversal initiatives
+ Build strong relationships with health authorities and regulatory bodies
+ Contribute to continuous improvement of regulatory systems and processes
**About you**
**You have exposure to regulatory affairs, clinical trials, or GMP within the pharmaceutical or biotech industry, and thrive in collaborative, fast-paced environments. You bring strong attention to detail and a focus on execution, along with excellent communication and teamwork skills. Technically, you're proficient in MS Office and database systems, and have a natural inclination toward digital and AI-driven tools.**
**Why choose us?**
+ Be part of a pioneering biopharma company where patient insights shape drug development
+ Work at the forefront of AI-powered science that accelerates discovery and improves outcomes
+ Explore bold career paths - with opportunities to grow through scientific, leadership, and cross-functional moves
+ Care for yourself and your loved ones with generous health and well-being benefits, including top-tier healthcare and 14 weeks' gender-neutral parental leave
+ Join a close-knit, ambitious team with a track record of internal growth and global career progression
+ Gain exposure to strategic projects and transversal regulatory initiatives
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary - together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Regulatory affairs specialist Jobs in Australia !
6
Regulatory Affairs Project Manager
Macquarie Park, New South Wales
Sanofi Group
Posted 12 days ago
Job Viewed
Job Description
**About the job**
As a Regulatory Affairs Project Manager within our Regulatory Affairs team, you'll lead and coordinate cross-functional regulatory projects across Australia and New Zealand. You'll manage strategic submissions, compliance initiatives, and transversal projects that impact the entire Sanofi portfolio. Based in Macquarie Park, this is a high-impact role with visibility across the business.
**About Sanofi**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main responsibilities**
+ Lead and execute regulatory submissions and lifecycle management across ANZ
+ Coordinate transversal projects with regulatory impact across the business
+ Manage vendor relationships, training, and budget oversight
+ Develop strategic regulatory approaches aligned with business goals
+ Ensure regulatory compliance and audit readiness
+ Represent Sanofi in industry groups and regulatory consultations
+ Monitor regulatory changes and communicate impacts to stakeholders
**About you**
**You bring proven experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of regulatory frameworks across Australia and New Zealand, as well as global standards. Your track record includes successful engagement with regulators and cross-functional teams, demonstrating strategic thinking and leadership capabilities. You're skilled in stakeholder management, communication, and presentation, and proficient in Microsoft Office and regulatory systems and overall, you thrive in managing complex projects and driving outcomes.**
**Why choose us?**
+ Be part of a pioneering biopharma company where patient insights shape drug development
+ Work at the forefront of AI-powered science that accelerates discovery and improves outcomes
+ Explore bold career paths - with opportunities to grow through scientific, leadership, and cross-functional moves
+ Care for yourself and your loved ones with generous health and well-being benefits, including top-tier healthcare and 14 weeks' gender-neutral parental leave
+ Lead impactful projects with visibility across the Sanofi portfolio
+ Collaborate with a high-performing, purpose-driven team in a globally connected environment
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary - together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
As a Regulatory Affairs Project Manager within our Regulatory Affairs team, you'll lead and coordinate cross-functional regulatory projects across Australia and New Zealand. You'll manage strategic submissions, compliance initiatives, and transversal projects that impact the entire Sanofi portfolio. Based in Macquarie Park, this is a high-impact role with visibility across the business.
**About Sanofi**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main responsibilities**
+ Lead and execute regulatory submissions and lifecycle management across ANZ
+ Coordinate transversal projects with regulatory impact across the business
+ Manage vendor relationships, training, and budget oversight
+ Develop strategic regulatory approaches aligned with business goals
+ Ensure regulatory compliance and audit readiness
+ Represent Sanofi in industry groups and regulatory consultations
+ Monitor regulatory changes and communicate impacts to stakeholders
**About you**
**You bring proven experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of regulatory frameworks across Australia and New Zealand, as well as global standards. Your track record includes successful engagement with regulators and cross-functional teams, demonstrating strategic thinking and leadership capabilities. You're skilled in stakeholder management, communication, and presentation, and proficient in Microsoft Office and regulatory systems and overall, you thrive in managing complex projects and driving outcomes.**
**Why choose us?**
+ Be part of a pioneering biopharma company where patient insights shape drug development
+ Work at the forefront of AI-powered science that accelerates discovery and improves outcomes
+ Explore bold career paths - with opportunities to grow through scientific, leadership, and cross-functional moves
+ Care for yourself and your loved ones with generous health and well-being benefits, including top-tier healthcare and 14 weeks' gender-neutral parental leave
+ Lead impactful projects with visibility across the Sanofi portfolio
+ Collaborate with a high-performing, purpose-driven team in a globally connected environment
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary - together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
This advertiser has chosen not to accept applicants from your region.
7
Quality Assurance & Regulatory Affairs Associate
Sydney, New South Wales
GN Hearing
Posted 12 days ago
Job Viewed
Job Description
Do you thrive in a fast-paced environment where quality and regulatory compliance are key to success? Are you an ISO 13485 expert with a keen eye for risk and continuous improvement? If so, GN Hearing Australia has the perfect opportunity for you!
We're on the lookout for a **Quality Assurance & Regulatory Affairs Associate** to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system - while helping improve lives through advanced hearing solutions.
As our QA/RA Associate, you'll:
+ Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
+ Support compliance with ISO13485 and local regulatory standards.
+ Act as the local Subject Matter Expert for quality processes and risk assessments.
+ Conduct internal audits and manage CAPAs, NCs, and quality records.
+ Drive validation activities for custom-manufactured products at our Sydney facility.
+ Collaborate with internal teams and corporate stakeholders across the globe.
+ Train and support teams on quality and regulatory matters.
+ Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
+ Be a key player in a high-performing, values-led QA/RA team.
We're looking for someone who:
+ Has a solid understanding of ISO 13485 and quality systems.
+ Knows their way around internal auditing, CAPA, and validation processes.
+ Is confident, detail-oriented, and self-motivated.
+ Communicates effectively with stakeholders at all levels.
+ Has 3+ years' experience in a QA/RA role, ideally in medical devices.
+ Is a natural problem-solver and thrives in a process-driven environment.
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.
GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding.
By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.
**The GN-owned brands that are responsible for bringing these technologies to life:**
+ Medical grade hearing technology: ReSound ( , Beltone ( , Interton ( , Jabra ( Professional collaboration: Jabra ( , BlueParrott ( , FalCom ( Gaming, calls and media: SteelSeries ( , Jabra ( in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.
If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn ( , Facebook ( and Twitter ( .
We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!
We're on the lookout for a **Quality Assurance & Regulatory Affairs Associate** to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system - while helping improve lives through advanced hearing solutions.
As our QA/RA Associate, you'll:
+ Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
+ Support compliance with ISO13485 and local regulatory standards.
+ Act as the local Subject Matter Expert for quality processes and risk assessments.
+ Conduct internal audits and manage CAPAs, NCs, and quality records.
+ Drive validation activities for custom-manufactured products at our Sydney facility.
+ Collaborate with internal teams and corporate stakeholders across the globe.
+ Train and support teams on quality and regulatory matters.
+ Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
+ Be a key player in a high-performing, values-led QA/RA team.
We're looking for someone who:
+ Has a solid understanding of ISO 13485 and quality systems.
+ Knows their way around internal auditing, CAPA, and validation processes.
+ Is confident, detail-oriented, and self-motivated.
+ Communicates effectively with stakeholders at all levels.
+ Has 3+ years' experience in a QA/RA role, ideally in medical devices.
+ Is a natural problem-solver and thrives in a process-driven environment.
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.
GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding.
By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.
**The GN-owned brands that are responsible for bringing these technologies to life:**
+ Medical grade hearing technology: ReSound ( , Beltone ( , Interton ( , Jabra ( Professional collaboration: Jabra ( , BlueParrott ( , FalCom ( Gaming, calls and media: SteelSeries ( , Jabra ( in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.
If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn ( , Facebook ( and Twitter ( .
We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!
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