Manager, Regulatory Affairs CMC with Viral Vector experience
Core
Lead Regulatory Affairs CMC for clinical and commercial cell therapy programs, ensuring high-quality regulatory deliverables and alignment with EMA/EU requirements.
Role type
Manager, Regulatory Affairs CMC
Builds
Regulatory CMC strategies, documentation, and submissions for CAR T-cell and cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / Oncology
Required skills
Viral vector and/or lipid nanoparticle experience, CMC regulatory strategy, EMA/EU/Ph. Eur. regulatory requirements, ATMP-specific expectations, cross-functional stakeholder influence, regulatory documentation authoring, change control assessment, industry network management
Preferred skills
PhD or MS degree, Dutch language proficiency, industry trade group participation
Technologies
Industry-standard regulatory software tools
Responsibilities
Author and review regulatory CMC documentation, interpret EMA/EU/Ph. Eur. requirements, assess CMC change controls, maintain regulatory IT systems, lead task forces for critical CMC issues, disseminate CMC best practices to the corporation
Seniority
Manager, hands-on IC with leadership responsibilities