We'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 At CSL, we're driven by our promise to patients and human health. We're also driven by our promise to employees, which is Promising Futures – our commitment to helping you fulfill your career aspirations and potential. You're our greatest asset and you help drive CSL's superior performance. We're committed to providing:
A workplace that's respectful of your professional and personal lives — and inclusive, so you feel comfortable bringing your whole self to work.Total rewards that include a competitive compensation package, comprehensive benefits, and multi-dimensional wellbeing programs and recognition programs, all of which support your physical, emotional, financial, and social health and wellbeing.Career, performance and development programs that enable success in your current position and foster your development and growth. 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 Our BenefitsCSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
About CSL Seqirus 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 speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus
