Regulatory Affairs Specialist

5 days ago


Melbourne, Victoria, Australia Gilead Full time
About the Role

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. We are seeking a knowledgeable and motivated professional to join our Regulatory Affairs team in Melbourne, Australia.

Key Responsibilities
  1. Prepare regulatory submissions for investigational and commercial products for Australia and New Zealand, ensuring compliance with ICH requirements and company policies.
  2. Submit marketing authorization and variations, as well as safety reports, amendments, supplements, and clinical trial applications as required.
  3. Provide local regulatory expertise for labeling changes and contribute to the preparation of country-specific labeling.
  4. Ensure product packaging and associated information is updated and maintained in accordance with product licenses.
  5. Participate in group meetings and present project status updates and strategy approaches to complex programs.
Requirements
  1. 8+ years of experience in Australian Regulatory Affairs.
  2. Extensive experience negotiating and interacting with the Therapeutic Goods Administration.
  3. Ability to perform as a senior member of a team with diverse membership from all functions and levels of the company.
  4. Degree in a scientific field is preferred.
Gilead Core Values
  1. Integrity (always doing the right thing)
  2. Teamwork (collaborating in good faith)
  3. Excellence (working at a high level of commitment and capability)
  4. Accountability (taking personal responsibility)
  5. Inclusion (encouraging diversity)


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