Regulatory Affairs Associate

6 months ago

Sydney, Australia Viatris Full time

1488 Alphapharm Pty. Ltd.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference; the Regulatory Affairs Associate role is key to ensure continuity of supply via life cycle maintenance activities for our existing portfolio and to support the registration of new medicines in Australia. Compliance to local and global regulations is essential in the ever-changing regulatory environment.

Key responsibilities for this role include:

- Lead and deliver regulatory submissions within required timeframes and consistent with TGA requirements;
- Ensure maintenance of allocated portfolio by carrying out activities associated with the change control process for CMC, artwork and labelling (Product Information) ;
- Collaborate with team members to develop regulatory strategies for allocated portfolio and new medicine submissions.
- Respond to TGA’s questions by liaising with local/global functions and external partners;
- Maintain Viatris database systems in compliance with internal requirements;
- Build and maintain effective collaboration with TGA personnel and other internal and external stakeholders;
- Keep up to date with new TGA requirements and processes;
- Contribute to departmental projects as required.

The minimum qualifications for this role are:

- Bachelor’s degree or equivalent in Pharmacy, Science or Chemistry;
- One years’ experience in regulatory affairs ideally with prescription medicines
- Understanding of local and international regulatory guidelines
- Capacity to investigate and evaluate a problem to develop effective solutions;
- Excellent communication skills (written and verbal);
- Ability to multitask and work to deadlines;
- Demonstrated ability to work well in a team environment and co-operate with others to achieve goals within specified timeframes;
- Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder).

Position Title: Regulatory Affairs Associate

Location: Sydney Head Office, Millers Point, NSW

Employment: Full Time, Permanent

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

  • Senior Regulatory Affairs Associate

    1 month ago

    Sydney, New South Wales, Australia Astra Zeneca Full time

    AstraZeneca is a global biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for serious diseases. We are seeking a Senior Regulatory Affairs Associate to join our team in Australia and New Zealand.About the RoleThis is an exciting opportunity for an experienced pharmaceutical regulatory...

  • Senior Regulatory Affairs Associate

    2 months ago

    North Sydney, Australia Novo Nordisk AS Full time

    Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines? If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. Read more and apply today for a life-changing career! About the department You will be part of the Clinical, Medical,...

  • Regulatory Affairs Associate

    3 weeks ago

    Sydney, Australia Colgate-Palmolive Full time

    No Relocation Assistance Offered Job Number #163782 - Sydney, New South Wales, Australia **Who We Are** Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the...

  • Senior Regulatory Affairs Associate

    2 months ago

    North Sydney, Australia Novo Nordisk Full time

    The position As a Senior Regulatory Affairs Associate, you will: Lead regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to assist product development, registration, and commercialisation. Manage the preparation, compilation, and timely submission of accurate regulatory...

  • Senior Regulatory Affairs Associate

    2 months ago

    Sydney, Australia Stryker Australia Pty Ltd Full time

    Work Flexibility: Hybrid If you are passionate about medical devices and regulatory affairs, then Stryker wants to talk to you. We are looking for a Senior Regulatory Affairs Associate  to join the high performing regulatory team. The successful candidate will bring experience to compliment the existing RA team of four. We are looking for someone who has...

  • Regulatory Affairs Associate

    6 months ago

    Sydney, Australia Abbott Laboratories Full time

    **Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.** We...

  • Senior Regulatory Affairs Associate

    1 month ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleJohnson & Johnson is seeking a highly skilled Senior Regulatory Affairs Associate to join their team. As a key member of the Regulatory Affairs team, you will be responsible for providing regulatory leadership and support for a portfolio of products.Key Responsibilities* Lead a product portfolio to plan regulatory strategies and manage local...

  • Regulatory Affairs Associate

    5 months ago

    Sydney, Australia Healthcare Professionals Group Full time

    **Benefits** - Great role to join a collaborative Medical Device organisation. - Exposure to diverse medical device portfolio - Hybrid working environment **About the Company** Our client is a leading Medical Device organisation with a strong presence in Australia, New Zealand, and Asia - they have a focus on quality and dedicated support, the company has...

  • Snr Regulatory Affairs Associate

    6 months ago

    Sydney, Australia S2M Digital Full time

    **Job Type**: - Full Time**Location**: - Sydney NSW**Classification**: - Legal**Sub Classification**: - Lawyer - Compliance**Reference #**: - 3684598**Contact Name**: - Brett Dickinson- **Salary**: - $130,000.00 - $165,000.00 Year Up to $160k packageAre you a Regulator Affairs Associate looking for a step up, or a Snr Regulatory Affairs Associate and...

  • Regulatory Affairs Specialist

    1 month ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    Are you passionate about regulatory affairs and eager to play a key role in ensuring the availability of life-changing medicines? We invite you to consider a career as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania.About the DepartmentYou will be part of the Clinical, Medical, Regulatory (CMR) Oceania team, reporting directly to the Senior...

  • Regulatory Affairs Associate

    3 weeks ago

    Sydney, Australia Colgate-Palmolive Full time

    No Relocation Assistance OfferedJob Number #163782 - Sydney, New South Wales, Australia Who We Are Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world,...

  • Regulatory Affairs Professional

    2 weeks ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Novo Nordisk A/S. This role offers an exciting opportunity for individuals passionate about regulatory affairs to play a key role in ensuring the availability of life-changing medicines.As a Senior Regulatory Affairs Associate, you will lead regulatory affairs activities...

  • Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    Stryker Australia Pty Ltd: Senior Regulatory Affairs Associate PositionWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team in Australia. The successful candidate will bring extensive experience in Regulatory Affairs, Class III and TGA conformity assessment applications, and a strong understanding of...

  • Regulatory Affairs Associate

    3 weeks ago

    Sydney, Australia Colgate-Palmolive Company Full time

    No Relocation Assistance OfferedJob Number #163782 - Sydney, New South Wales, AustraliaWho We AreColgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world,...

  • Regulatory Affairs Associate

    6 months ago

    Sydney, Australia Lula Group Full time

    Hybrid working model - Highly-known company across APAC - Long term career progression **About the Company** Our client, a renowned Pharmaceutical company with a strong presence across the APAC region, is in the process of expanding its headquarters in Sydney. They are currently looking to add a skilled Regulatory Affairs Associate to their growing team....

  • Regulatory Affairs Professional

    4 weeks ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    About the RoleNovo Nordisk A/S is seeking a highly skilled Senior Regulatory Affairs Associate to join our Clinical, Medical, Regulatory (CMR) Oceania team. As a key member of the team, you will be responsible for leading regulatory affairs activities for assigned products in Australia and New Zealand.Key Responsibilities• Lead regulatory affairs...

  • Regulatory Affairs Specialist

    1 month ago

    Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    We are seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team at Stryker Australia Pty Ltd.The ideal candidate will have at least 5 years of experience in Regulatory Affairs, with a strong background in Class III and TGA conformity assessment applications.Responsibilities will include preparing and submitting...

  • Regulatory Affairs Associate, Health

    6 months ago

    Sydney, Australia Reckitt Full time

    Want to see your expertise recognised? As a Regulatory Affairs Associate you’ll have the freedom to influence decisions that shape our next generation of leading brands. Regulatory Affairs Associate Sydney Based Position - WFH/Office Hybrid Environment Competitive Salary & excellent benefits package Critical for driving innovation and optimising our...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full time

    At Device Technologies Australia Pty Ltd, we are driven by a vision to improve patients' lives through innovative medical solutions.We are seeking a highly skilled Regulatory Affairs Associate to join our team in Sydney. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local requirements and regulations for...

  • Regulatory Affairs Director

    7 days ago

    Sydney, New South Wales, Australia PharmaLex Full time

    About the Opportunity We are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. This role will involve working with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective will be to maximize client commercial success by ensuring appropriate...