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Regulatory Affairs Specialist CMC
2 months ago
We're seeking a highly skilled Principal Associate, Regulatory Affairs CMC to join our team at CSL Seqirus. In this strategic role, 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:
Main Responsibilities:- Develop and implement the global CMC regulatory strategy for Seqirus development programs/products, licensed 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.
- 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.
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of specialty pharmaceuticals and other essential vaccines.
We want CSL Seqirus to reflect the world around us. As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion.
Do work that matters at CSL Seqirus. Watch our 'On the Front Line' video to learn more about CSL Seqirus.
