Regulatory Affairs Manager

5 days ago


Melbourne, Victoria, Australia Gilead Sciences, Inc. Full time
Senior Manager, Regulatory Affairs

Gilead Sciences, a leading biopharmaceutical company, is seeking a highly skilled and experienced Senior Manager, Regulatory Affairs to join its Melbourne, Australia team. As a key member of the Regulatory Affairs department, you will be responsible for preparing regulatory submissions, interacting with various departments, and ensuring compliance with ICH requirements and company policies.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with Australian and New Zealand regulations.
  • Collaborate with cross-functional teams to prepare regulatory submissions, including marketing authorizations and variations.
  • Provide local regulatory expertise for labelling changes and contribute to the preparation of country-specific labelling.
  • Ensure product packaging and associated information is updated and maintained in accordance with product licenses.
  • Participate in group meetings and present project status updates and strategy approaches to complex programs.

Requirements:

  • 8+ years of experience in Australian Regulatory Affairs.
  • Extensive experience negotiating and interacting with the Therapeutic Goods Administration.
  • Ability to perform as a senior member of a team with diverse membership from all functions and levels of the company.
  • Degree in a scientific field is preferred.

About Us:

Gilead Sciences, Inc. is a biopharmaceutical company committed to advancing innovative medicines to prevent and treat life-threatening diseases. With a presence in over 35 countries, we strive to create a healthier world for all people.



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