Senior Regulatory Professional

7 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000

We are seeking an experienced Regulatory Affairs Specialist to join our team.

The successful candidate will have strong negotiation skills and experience interacting with regulatory authorities, industry associations, internal and external stakeholders.

This role will play a critical part in ensuring compliance with regulatory requirements in Australia and New Zealand (ANZ).

The ideal candidate will be able to think strategically and critically evaluate risks to regulatory activities.

The responsibilities of this position include:

  • Maintaining awareness of regulatory requirements
  • Compiling and preparing responses to questions from regulatory authorities
  • Participating as an active team member of project teams as required

The Regulatory Information Management system will be used for registrations, submissions, and associated lifecycle management of regulatory data.

A key responsibility of the Regulatory Affairs Specialist will be to track status and progress of regulatory documentation, prepare and review AdProm materials for compliance with local regulations.

To be considered for this role, you should have a Bachelor's degree in science, in a relevant scientific discipline; postgraduate qualifications in a relevant scientific discipline will be an advantage.

You will also need a minimum of 2-year regulatory experience in RA or equivalent experience within a medical device and/or pharmaceutical.

We are committed to attracting and retaining talented individuals who share our values and passion for delivering high-quality outcomes.

This is a fantastic opportunity for someone looking to take their career to the next level and make a meaningful contribution to the field of regulatory affairs.

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