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, global regulatory compliance, stakeholder management, project prioritization, risk mitigation, regulatory assessment, cross-functional collaboration, strategic guidance
Preferred skills
Biotechnology or cell therapy product knowledge, people management experience, coaching and mentoring, expertise in biological and cell therapy modalities, upstream/downstream process knowledge, analytical methods knowledge
Technologies
Regulatory Information Management systems, electronic dossier creation systems
Responsibilities
Lead and develop a diverse, high-performing team of CMC regulatory professionals; oversee the preparation and review of CMC submissions for clinical trials, marketing applications, and post-approval changes; act as the primary interface between Global Regulatory Sciences and Cell Therapy Development Operations; provide strategic guidance on regulatory requirements and expectations for cell therapy products; manage relationships with diverse teams and Health Authorities; interpret global regulations and identify regulatory opportunities and risks.
Seniority
Senior, hands-on IC with leadership responsibilities