Principal Associate Regulatory Affairs Cmc

Principal Associate Regulatory Affairs CMCWe're looking for a Principal Associate, Regulatory Affairs CMC to join our team. In this strategic position, you will provide specialist strategic advice and support to Project/Product teams, Quality and Operations. Reporting to the local Head of GRA CMC your main responsibilities include:Develop and implement the global CMC regulatory strategy for Seqirus development programs/products, licenced through all development phases to registration/licensure and approval/post approval lifecycle stages.In association with GRA Regions colleagues ensure CMC dossiers meet content requirements for applicable territories.Lead sub-teams of regulatory and cross-functional experts to ensure author, preparation and compilation of high quality, submission ready CMC documentation for HA submissions in Seqirus territories.Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes.Provide strategic regulatory expertise and guidance for the development and review of technical protocols and reports.Your Experience:Tertiary Degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with post-graduate qualifications, or complementary experience in the pharmaceutical/ biotechnology industry.3+ years' regulatory experience with specific knowledge and experience in CMC preferred.Experience in a biologicals or biotechnology manufacturing environment e.g., QA, manufacturing or technical/product development advantageous.Excellent project management skills.If you are looking to join a purpose-driven, values-based organisation committed to protecting public health, apply now!Applications Close on 6 October, 2024
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