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 documentation and strategies for CAR T-cell and cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / Viral Vectors
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Viral vector experience, Lipid nanoparticle experience, Regulatory strategy development, Cross-functional stakeholder alignment, Regulatory documentation authoring, Change control assessment, International regulatory interpretation (EMA/EU/Ph. Eur.), Industry network management
Preferred skills
Dutch language proficiency, Advanced degree (PhD/MS)
Technologies
Industry-standard regulatory software tools
Responsibilities
Author and review regulatory CMC documentation, Contribute to CMC regulatory strategies, Interpret EMA/EU/Ph. Eur. and ATMP requirements, Assess CMC change controls for regulatory impact, Maintain internal regulatory IT systems, Participate in industry trade groups, Lead updates on international CMC guidance, Assist in drafting background packages for Health Authority meetings
Seniority
Manager, hands-on IC