Director, International CMC Regulatory Affairs – Cell and Gene Therapy
Core
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 (Cell and Gene Therapy)
Builds
International CMC strategies, high-quality regulatory submissions (BLAs, MAAs, master files), and health authority briefing materials.
Domain
Biopharmaceuticals, Cell and Gene Therapy, Regulatory Affairs
Required skills
Global CMC regulatory requirements knowledge, Cell and gene therapy development experience, Health authority interaction management, Complex submission leadership, Cross-functional stakeholder management, Risk management and mitigation, Strategic direction for manufacturing changes, Policy shaping and advocacy
Preferred skills
Postgraduate qualification in regulatory or business discipline, Manufacturing and supply chain understanding, Due diligence and in-licensing 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, development, and supply functions, Contribute to internal and external policy shaping, Drive agile approaches to CMC dossier management, Lead knowledge sharing and coaching, Support business improvement initiatives, Provide regulatory leadership for due diligence and business development activities, Lead cross-functional teams in a matrix environment
Seniority
Director, strategic leadership and matrix team management