Hands-on and strategic, the full-time salaried Regulatory CMC Associate Director will develop and execute multi-product global regulatory CMC strategies for investigational products, manage regulatory submissions, and provide guidance to cross-functional teams while working remotely. Key responsibilities: Leads the preparation and review of CMC sections of global regulatory submissions and manages interactions with regulatory agencies Defines CMC content requirements for regulatory submissions and ensures compliance with established regulations Stays updated on evolving regulatory CMC requirements and provides guidance to cross-functional teams on compliance topics Required qualifications: Bachelor's Degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Regulatory Affairs) Minimum 10 years of experience in the vaccine or biotech industry, or equivalent combination of education and experience Prior experience preparing/authoring CMC DS sections, with BLA and IND experience highly preferred Advanced knowledge of regulatory guidelines (FDA, EMA, Health Canada, ICH) Strong strategic thinking and problem-solving skills
Regulatory CMC Associate Director • Knoxville, Tennessee, United States
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