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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global CMC regulatory strategy, IND/IMPD/BLA/MAA filing experience, cross-functional team leadership, risk management, health authority engagement, lifecycle dossier management, standards development, people leadership
Preferred skills
CGT comparability strategies, potency assays, control strategy development, eCTD publishing tools, expedited pathway delivery, matrixed environment experience, analytics/automation for regulatory processes
Technologies
eCTD publishing tools, document management systems
Responsibilities
Develop and implement global CMC regulatory strategies; interpret global regulations to identify risks and provide actionable input; deliver CMC components for submissions and health authority briefing documents; manage regulatory dossiers throughout the product lifecycle; develop and maintain regulatory templates and best practices; lead workflow and develop staff
Seniority
Director, strategic leadership with hands-on program oversight