Regulatory Affairs Associate

2 days ago

Sydney, Australia Sandoz Full time

5 million. This is the number of products that Sandoz, a part of the Novartis Group of Companies, distributes into the Australian & New Zealand market every single month. Join the Team of the Year at Sandoz ANZ where you can actively contribute to this number by managing and maintaining current GMP for existing and new manufacturing sites to support supply continuity, ensure compliance with all corporate and local requirements, partner with relevant stakeholders to assist registering complex and interesting products and to expand an already compelling Sandoz product portfolio.
- This is a great opportunity to use your existing project management skills and/or Regulatory Affairs experience to be part of a business improving access to medicine for more people across the country. As a Regulatory Affairs Associate GMP, your role will be to prepare, submit and maintain GMP clearance renewals, create and maintain processes and services through cross-functional team activity and compliance of processes, services, and products in the Australian and New Zealand market.
- Your responsibilities include, but not limited to:
- Ensures rapid and timely approval for GMP renewals, new submissions and continued approved status for all registered manufacturing sites
- Maintenance of GMP database and related trackers to ensure regulatory history is traceable and regulatory documents are easy to locate
- Coordinates, reviews, and may prepare reports

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- What you’ll bring to the role:

- To be successful in this role, you will bring:
- Tertiary education in Pharmacy, Science, Chemistry or related
- 2 years plus experience working in the pharmaceutical industry, ideally in Regulatory Affairs in the Australian market
- Demonstrated project management and stakeholder management skills -the ability to engage with and gain information from a wide variety of sources, in order to achieve your goals
- Excellent verbal and written communication skills; ability to work within a highly matrix driven environment

Why consider Sandoz?
- Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

**Division**
- SANDOZ

**Business Unit**
- Commercial OPS SIR SZ

**Country**
- Australia

**Work Location**
- Sydney

**Company/Legal Entity**
- AU Sandoz Pty ltd

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- Yes

  • Regulatory Affairs Associate

    2 days ago

    Sydney, Australia Bausch + Lomb Full time

    REGULATORY AFFAIRS ASSOCIATE - Fixed Term Control Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to...

  • Regulatory Affairs Associate

    1 week ago

    Sydney, Australia Pfizer Full time

    Why Patients Need You This is a great opportunity to become part of a dedicated and successful Regulatory Department and to help us make a meaningful difference to the lives of patients in Australia and New Zealand. Our Team is talented, collaborative, diverse and made up of experienced regulatory professionals who always strive for the best outcomes for...

  • Regulatory Affairs Associate

    1 week ago

    Sydney, Australia Viatris Full time

    3801 Upjohn Australia 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...

  • Regulatory Affairs Associate

    5 days ago

    Sydney, Australia OneMD Pty Ltd Full time

    Working with Class III consumbale devices - Can be located in any major city across Australia - Excellent company for career progression Our client is one of Australia’s leading independent medical device distributors. They are growing at a rapid rate after strategic acquisitions across the globe. Which in turn means a strong pipeline of new products....

  • Regulatory Affairs Associate

    4 days ago

    Sydney, Australia Coadys Personnel Full time

    Our client is a successful and rapidly expanding pharmaceutical manufacturing organisation. With a large team of around 70 staff, this position will be responsible for ensuring all regulatory activities for the business and it's customers adhere to the requirements of regulatory bodies and company standards. Working closely with internal teams (QA, Sales,...

  • Regulatory Affairs Associate

    1 week ago

    Sydney, Australia Pfizer Full time

    Use Your Power for Purpose We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized...

  • Regulatory Affairs Manager

    2 days ago

    Sydney, Australia Goodman Full time

    Advisory role working across multiple food categories - Autonomous role - ability to make the role your own! - Macquarie Park based with WFH 2 days a week At Goodman Fielder our purpose is making everyday food better for everyone. Our aspiration is to be the leading integrated food solutions business in the region. We are a team that believes that anything...

  • ▷ (6/10/2025) Senior Regulatory Affairs Associate

    1 week ago

    Council of the City of Sydney, Australia DBG Health Pty Full time

    We are seeking a Senior Regulatory Affairs Associate to join our high-performing Regulatory Affairs team. About the Company DBG Health & Arrotex Pharmaceuticals: DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,500 dedicated professionals, we are committed to delivering affordable...

  • Advisor, Regulatory Affairs

    4 days ago

    Sydney, Australia Australian Prudential Regulation Authority (APRA) Full time

    **The role** **The team** APRA’s Regulatory Affairs team sits within the Chief of Staff and Enterprise Services Division alongside APRA’s Corporate Affairs, Strategy & Governance, Finance, People & Culture, and Operations functions. Our Regulatory Affairs team leads APRA’s domestic engagement (e.g. liaison with ASIC, RBA, Treasury, AUSTRAC and...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, Australia Medella Life Full time

    Location- Sydney- Contact name: - Ethan Keating- Job ref: - 827- Published: - about 2 hours ago**Job Title: Regulatory Affairs Specialist (12-month Contract)** **Location: Hybrid - Sydney, Australia** **Key Responsibilities**: - **Regulatory Compliance**: - Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector,...