Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)
Core
Develop and execute the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies, ensuring submission-ready modules for health authorities.
Role type
Senior IC regulatory affairs lead (CMC, CGT)
Builds
Regulatory dossiers (IND/IMPD/BLA/Master Files) and health authority interaction briefing documents for cell and gene therapy products.
Domain
Biopharmaceuticals, Cell & Gene Therapies, CMC Regulatory Affairs
Required skills
Global CMC regulations knowledge, IND/IMPD/BLA/MAA filing experience, technical risk assessment, manufacturing change assessment, regulatory template development, cross-functional team leadership, multi-project prioritization
Preferred skills
Cell/gene therapy prior experience, health authority interaction experience
Technologies
Regulatory submission systems, document management tools
Responsibilities
Interpret global regulations to identify risks, partner with stakeholders to deliver regulatory dossiers, support Reg CMC activities in complex programs, provide regulatory assessments for manufacturing changes, represent CMC regulatory affairs in health authority interactions, develop and maintain regulatory templates and procedures
Seniority
Senior, hands-on IC with supervisory responsibilities