Regulatory CMC Director (Cell & Gene Therapy)
Core
Lead global CMC regulatory strategy for cell and gene therapy programs, translating science into high-quality submissions and health authority interactions to accelerate patient access.
Role type
Director, Regulatory CMC (Cell & Gene Therapy)
Builds
IND, IMPD, BLA, Master Files, and annual reports for cell and gene therapy products.
Domain
Biopharmaceuticals / Cell & Gene Therapy
Required skills
Global CMC regulations, IND/IMPD/BLA/MAA filings, cross-functional leadership, risk management, dossier leadership, lifecycle management, team building, strategic planning
Preferred skills
Health authority negotiation, CGT comparability strategies, potency assays, control strategy development, eCTD publishing tools, accelerated approval pathways, analytics/automation
Responsibilities
Develop global CMC regulatory strategies, interpret global regulations to identify risks, deliver CMC components for submissions, manage regulatory dossiers throughout the lifecycle, develop regulatory templates and best practices, lead and develop staff
Seniority
Director, strategic leadership with hands-on execution