Senior Manager, CMC Regulatory Affairs (Biologics)

Role: Senior Manager, CMC Regulatory Affairs, providing strategic and operational regulatory leadership for biologic drug development and commercialization, focusing on late-stage and rare disease therapeutics. Responsibilities: develop and execute global CMC regulatory strategies supporting clinical trials, registration, and lifecycle management; lead CMC documentation for filings like INDs, BLAs, NDAs, and amendments; manage health authority interactions; ensure compliance with global regulations; support manufacturing process development, comparability, and control strategies; provide regulatory guidance for biologics such as monoclonal antibodies and recombinant proteins; collaborate with cross-functional teams including manufacturing, process development, and quality. Requirements: Bachelor's degree in a scientific discipline, with 7+ years in biotech/pharma regulatory affairs, especially biologics; extensive experience supporting Phase 3 and late-stage development; proven history of global regulatory submissions and health authority interactions; strong technical knowledge of biologic manufacturing, analytical characterization, and lifecycle management. HighValue: biologics, monoclonal antibodies, recombinant proteins; late-stage development (Phase 3); global CMC regulatory strategy and submissions; rare disease/ orphan indications experience; supporting manufacturing process development and post-approval changes. WorkSetup: remote with up to 10% travel; based in San Diego, USA.