Regulatory Affairs Associate

6 days 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.

  • Regulatory Affairs Associate

    1 day ago

    Sydney, Australia Novo Nordisk Full time

    Regulatory Affairs Associate **Category**:Reg Affairs & Safety Pharmacovigilance **Location**:North Sydney, New South Wales, AU **Regulatory Affairs Associate** **Clinical, Medical & Regulatory (CMR)** **Sydney, Australia** - Are you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products? If...

  • Regulatory Affairs Associate

    4 weeks ago

    Sydney, New South Wales, Australia Beiersdorf Full time

    Join to apply for the Regulatory Affairs Associate role at BeiersdorfJoin to apply for the Regulatory Affairs Associate role at BeiersdorfTHE ROLEWe have an exciting opportunity available for someone to join Beiersdorf in this Regulatory Affairs Associate position. In this role, you will assist and support the organisation in maintaining an efficient,...

  • Regulatory Affairs Associate

    4 weeks ago

    Sydney, New South Wales, Australia Beiersdorf Full time

    Join to apply for the Regulatory Affairs Associate role at BeiersdorfJoin to apply for the Regulatory Affairs Associate role at BeiersdorfTHE ROLEWe have an exciting opportunity available for someone to join Beiersdorf in this Regulatory Affairs Associate position. In this role, you will assist and support the organisation in maintaining an efficient,...

  • Regulatory Affairs Associate

    2 weeks 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

    2 weeks ago

    Sydney, New South Wales, Australia Roche Full time

    Join to apply for the Regulatory Affairs Associate | ANZ role at RocheJoin to apply for the Regulatory Affairs Associate | ANZ role at RocheAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia Roche Full time

    Join to apply for the Regulatory Affairs Associate | ANZ role at RocheJoin to apply for the Regulatory Affairs Associate | ANZ role at RocheAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who...

  • Regulatory Affairs Associate

    3 weeks ago

    Sydney, New South Wales, Australia 3801 Upjohn Australia Pty Ltd. Full time

    Regulatory Affairs Associate page is loadedRegulatory Affairs AssociateApply locations Sydney, New South Wales, Australia time type Full time posted on Posted 8 Days Ago job requisition id R5661486 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...

  • Regulatory Affairs Associate

    3 weeks ago

    Sydney, New South Wales, Australia 3801 Upjohn Australia Pty Ltd. Full time

    Regulatory Affairs Associate page is loadedRegulatory Affairs AssociateApply locations Sydney, New South Wales, Australia time type Full time posted on Posted 8 Days Ago job requisition id R5661486 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...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia 3801 Upjohn Australia Pty Ltd. Full time

    Regulatory Affairs Associate page is loadedRegulatory Affairs AssociateApply locations Sydney, New South Wales, Australia time type Full time posted on Posted 8 Days Ago job requisition id R5661486 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...

  • Regulatory Affairs Associate

    4 weeks ago

    Sydney, New South Wales, Australia Viatris Inc. Full time

    Regulatory Affairs Associate page is loadedRegulatory Affairs AssociatePostuler locations Sydney, New South Wales, Australia time type Temps plein posted on Offre publiée hier job requisition id R5661486 Upjohn Australia Pty Ltd.Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et...