Senior Manager, CMC Regulatory Affairs; Biologics

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.

• 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.

• 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.

• 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.

remote with up to 10% travel; based in San Diego, USA.