Associate Principal Scientist, Regulatory Affairs

Role: Associate Principal Scientist, Regulatory CMC - Biologics (equivalent to Associate Director), focusing on developing and implementing global regulatory strategies for biologics products, including INDs, BLAs, and post-approval changes. Responsibilities: preparing and submitting CMC sections, authoring regulatory documents, assessing global guidelines, tracking submissions, and collaborating with cross-functional teams to ensure compliance and scientific accuracy. Mentors junior staff and supports program development and process improvements. Requirements: B.S. in a science or engineering field (advanced degree preferred), 10+ years of biologics CMC regulatory experience including IND/BLA filings, agency interactions, and technical assessments. Skills: deep knowledge of global CMC regulatory guidelines, strong communication, leadership, project management, and problem-solving abilities. Preferred: experience with antibody-drug conjugates, complex biologics, and advanced modalities. High-Value: biologics development, regulatory filings, global strategy, cross-functional collaboration, international compliance, and experience with complex dosage forms. Work setup: hybrid in the US; travel details not specified.