Compliance Specialist

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000

This is an exciting opportunity for a Regulatory Affairs Manager to join our team and lead product registration and compliance in Australia and New Zealand.

We are seeking a highly skilled professional with expertise in regulatory affairs, who can prioritize and accelerate the registration of company products (Pharmaceuticals) and maintain marketing authorizations of existing products.

The successful candidate will be responsible for developing and implementing regulatory strategies aligned with business objectives, ensuring ongoing compliance with regulatory requirements, and representing the company in quality matters.

Key responsibilities include:

  • Communicating ANZ submission requirements to regional and global collaborators
  • Developing and implementing regulatory strategies
  • Maintaining marketing authorizations for existing products
  • Ensuring compliance with regulatory requirements
  • Representing the company in day-to-day quality matters

The ideal candidate will have a tertiary degree in Pharmacy or a related scientific field, minimum 8 years of experience in Regulatory Affairs in the Australian/New Zealand pharmaceutical industry, and proven experience working closely with the TGA.

In addition, the candidate should possess strong analytical skills, ability to identify optimization procedures, and develop guidelines as needed.

We offer a dynamic and inclusive work environment, where employees can collaborate effectively and feel valued and respected.

We are committed to delivering support structures for working families, stronger actions to address pay inequalities, and strategic recruitment and promotion practices that help to encourage the full participation of all people at work.

Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law.

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