Senior Manager, CMC Regulatory Affairs (Biologics)

Role: Senior Manager, CMC Regulatory Affairs, providing strategic and operational leadership for biologics CMC regulatory activities in late-stage development and commercialization. Responsibilities: develop and execute global CMC regulatory strategies, lead regulatory submissions (INDs, BLAs, NDAs, etc.), manage Health Authority interactions, support lifecycle management changes, and provide technical guidance across biologics development programs (monoclonal antibodies, recombinant proteins, fusion proteins). Collaborate closely with Technical Operations, Process Development, Manufacturing, Quality, and Regulatory teams to ensure compliance with global regulatory standards. Requirements: Bachelor's in a scientific discipline; 7+ years in biotech/pharma regulatory affairs with significant biologics CMC experience; proven support of Phase 3 and late-stage programs; experience with global regulatory submissions and lifecycle management. Preferred: advanced degree (MS, PhD, PharmD), experience supporting rare disease biologics, knowledge of FDA, EMA, and other global regulations. High-Value: biologics (mAbs, recombinant proteins), late-stage development, global regulatory submissions, lifecycle management, rare disease focus. WorkSetup: remote with up to 10% travel; based in San Diego.