Director, Regulatory - CMC

Job Title: Director, Regulatory CMCLocation: San Francisco, CA (Onsite 4 days/week)Industry: Biotechnology / PharmaceuticalJob SummaryWe are seeking an experienced Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) to join a growing biotech organization. This role will lead regulatory strategy and execution for CMC activities across development programs, with exposure to both small molecules and biologics.The ideal candidate will bring strong expertise in global regulatory requirements and play a key role in supporting product development, submissions, and lifecycle management.Key ResponsibilitiesLead and develop CMC regulatory strategies to support clinical development and commercializationPrepare and review regulatory submissions (INDs, NDAs, BLAs, amendments, and supplements)Ensure compliance with FDA, EMA, and global regulatory requirementsCollaborate cross-functionally with CMC, Quality, Manufacturing, and Clinical teamsProvide regulatory guidance on process development, manufacturing changes, and product lifecycle managementSupport interactions with regulatory agencies, including meeting preparation and responsesOversee preparation and review of Module 3 (CMC) documentationStay current with evolving regulatory requirements and industry trendsRequired QualificationsBachelor s degree in Life Sciences, Chemistry, or related field (advanced degree preferred)10+ years of experience in Regulatory Affairs (CMC) within biotech/pharmaStrong experience with IND, NDA, BLA submissionsExperience with both small molecules and/or biologics (both preferred)Deep understanding of global regulatory guidelines (FDA, EMA, ICH)Excellent communication, leadership, and stakeholder management skills