Director, Regulatory CMC - Cell Therapy
Core
Oversee management of multiple development and life-cycle management projects for cell therapy and advanced therapies, representing the company with Health Authorities and cross-functional teams.
Role type
Director, Regulatory CMC (Cell Therapy)
Builds
CMC submissions and global regulatory strategies for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / Regulatory Affairs
Required skills
CMC regulatory requirements for advanced therapies, pharmaceutical development (upstream/downstream), analytical methods, global regulatory strategy, cross-functional team leadership, stakeholder management, policy and law interpretation
Preferred skills
Multidisciplinary experience, negotiation, conflict management, strategic planning, matrix organization navigation
Technologies
Electronic dossier systems
Responsibilities
Develop and communicate strategic direction based on global regulatory guidelines, prepare or oversee CMC submissions, review submissions for clarity, manage direct reports, anticipate regulatory paradigm shifts, participate in product fact-finding and R&D forums, support policy development, ensure regulatory compliance via data entry monitoring
Seniority
Director, strategic leadership & team management