Director, International CMC Regulatory Affairs – Cell and Gene Therapy
Core
Provides strategic, operational, and tactical CMC regulatory leadership for a portfolio of cell and gene therapies and biologics across clinical development, registration, launch, and post-approval lifecycle management.
Role type
Director, International CMC Regulatory Affairs
Builds
International CMC strategies, regulatory submissions (BLAs, MAAs, master files), and health authority interactions
Domain
Biopharmaceuticals, Cell and Gene Therapy, Regulatory Affairs
Required skills
Global CMC regulatory knowledge, Cell and gene therapy development experience, Strategic regulatory planning, Health authority interaction, Cross-functional stakeholder management, Risk management, Project leadership, Scientific and manufacturing understanding
Preferred skills
Postgraduate qualification, Health authority advocacy experience, Manufacturing and supply chain knowledge, Due diligence and business development experience
Technologies
BLA, MAA, IND, IMPD, Master files
Responsibilities
Lead development of international CMC regulatory strategies, Interpret global CMC regulations and guidance, Represent company with international trade associations and health authorities, Identify and manage complex regulatory risks, Provide strategic direction for manufacturing changes and quality compliance, Lead or coordinate high-quality CMC submission content, Ensure regulatory activities meet quality and timeline standards, Represent on technical and regulatory product teams, Lead responses to health authority questions, Build networks across regulatory and operational functions, Contribute to policy shaping and regulatory strategy, Drive agile approaches to dossier management, Lead knowledge sharing and coaching, Support business improvement initiatives, Provide regulatory leadership for due diligence and business development activities
Seniority
Director, strategic leadership and cross-functional influence