Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)
Core
Develop and execute the CMC regulatory strategy for the innovative Cell & Gene Therapies pipeline, ensuring submission-ready modules and managing regulatory dossiers throughout the product development lifecycle.
Role type
Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)
Builds
Regulatory dossiers (IND/IMPD/BLA/Master Files), health authority interaction briefing documents, and submission-ready CMC modules.
Domain
Biopharmaceuticals, Cell & Gene Therapies, CMC (Chemistry, Manufacturing, and Controls)
Required skills
Global CMC regulations knowledge, regulatory dossier management, technical risk assessment, manufacturing change assessment, cross-functional team leadership, regulatory template development
Preferred skills
Cell/gene therapy experience, IND/IMPD/BLA/MAA filing experience
Technologies
Regulatory submission systems, AstraZeneca systems
Responsibilities
Interpret global regulations to identify risks and provide guidance; Partner with stakeholders to deliver regulatory dossiers and briefing documents; Represent CMC regulatory affairs in health authority interactions; Provide regulatory assessments for manufacturing changes and quality compliance; Support development of regulatory templates and best practices.
Seniority
Associate Director, supervisory role