Regulatory CMC Director (Cell & Gene Therapy)

Role: Lead global CMC regulatory strategy for cell and gene therapies, overseeing all development stages to ensure efficient approvals and risk management. Responsibilities: develop and implement regulatory pathways, interpret global regulations, prepare and submit CMC dossiers (INDs, BLA, etc.), manage lifecycle documentation, lead health authority interactions, and build best practices; support team development and continuous process improvements. Requirements: MA/MS in life sciences, 8+ years (MS) or 6+ years (PhD) experience in CMC/regulatory affairs, with strong knowledge of global regulations, especially for cell and gene therapies; prior experience with IND, BLA filings, and health authority negotiations. Preferred: expertise in CGT-specific assays, comparability, potency, and control strategies; familiarity with eCTD tools; record of expedited approvals; experience in multi-site, high-growth environments. HighValue: cell and gene therapy, advanced therapy medicinal products, global CMC regulation, IND/BLA submissions, health authority engagement, lifecycle management. WorkSetup: based in Santa Monica, CA or Gaithersburg, MD, with flexible work arrangements.