Associate Director -GRS CMC cell therapy
Core
Lead a team of CMC regulatory professionals to develop global regulatory strategies, oversee submissions, and manage manufacturing change controls for cell therapy and biologics products.
Role type
Senior IC regulatory director (cell therapy/biologics)
Builds
Global regulatory CMC strategies and submissions for cell therapy and biologics
Domain
Biopharmaceuticals / Cell Therapy / Regulatory Affairs
Required skills
CMC regulatory strategy, team leadership, manufacturing change control assessment, Health Authority interaction, global regulatory interpretation, project prioritization, cross-functional partnership
Preferred skills
Biotechnology or cell therapy product knowledge, people management experience, coaching and mentoring, expertise in biological modalities and drug development processes
Technologies
Regulatory Information Management systems, electronic dossier creation tools
Responsibilities
Lead and develop a diverse team of CMC regulatory professionals; oversee preparation and review of CMC submissions for clinical trials and marketing applications; assess manufacturing change controls for global impact; represent GRS-CMC on cross-functional teams and governance committees; interface with Health Authorities on CMC submissions; interpret global regulations to identify risks and opportunities; provide strategic guidance to development teams on regulatory expectations.
Seniority
Senior, hands-on IC with team leadership