Regulatory Affairs Associate

3 weeks ago

Sydney, Australia Viatris Full time

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 and experience for this role are:

- Bachelor’s degree or equivalent in Pharmacy, Science or Chemistry.
- Two 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, Fixed Term - February 2025

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.

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