Regulatory CMC Associate Director

Providing strategic and operational support, the full-time salaried Regulatory CMC Associate Director will develop and execute multi-product global regulatory CMC strategies for investigational products, lead regulatory submissions, and manage interactions with Health Authorities, all while working remotely. Key responsibilities: Leads the preparation and review of CMC sections of global regulatory submissions and manages interactions with regulatory agencies Provides CMC regulatory guidance to cross-functional teams and key stakeholders, ensuring compliance with EMA/FDA/ICH regulations Stays current on evolving regulatory CMC requirements and shares knowledge with team members to support product development 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 education and experience Prior experience preparing/authoring CMC sections for BLA, INDs, or post-approval supplements highly preferred Experience with regulatory guidelines (FDA, EMA, Health Canada, ICH) Strong strategic thinking and problem-solving skills #J-18808-Ljbffr Vaxcyte