Provide global regulatory CMC leadership and strategy across the development, lifecycle management, and commercialization of cell therapy and viral vector–based products
Lead the development, compilation, review, and maintenance of CMC sections for global regulatory submissions
Serve as a key strategic interface between Global Regulatory Affairs, Research, Technical Operations, Quality, and external partners
Ensure global harmonization of CMC content across submissions
Assess manufacturing change controls for global regulatory impact
Identify CMC regulatory risks and develop mitigation strategies
Guide technical teams on global CMC regulatory requirements throughout development and post-approval stages
Independently manage and prioritize multiple complex programs and submissions

12 years experience with a BA/BS degree or 10 years of relevant experience with a master's degree
8 years with a PhD (or equivalent education) in a scientific or related discipline
Minimum 10+ years of pharmaceutical/biotechnology industry experience, including 7+ years in Regulatory Affairs CMC
Strong experience with cell therapy and/or viral vector–based products; ATMP experience strongly preferred
In-depth knowledge of global CMC regulatory requirements across development and post-approval phases
Demonstrated expertise in biopharmaceutical development, including drug substance/drug product manufacturing, sterile products, and analytical methods
Solid understanding of ICH guidelines, cGMP requirements, and global regulatory expectations
Proven experience supporting regulatory inspections and health authority engagements
Demonstrated ability to author and critically review complex CMC sections and to lead CMC sub-teams

Director, Regulatory Affairs CMC

Key skills