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 processes), analytical methods, global regulatory guidelines, cross-functional team leadership, strategic planning, stakeholder management, electronic dossier systems
Preferred skills
Multidisciplinary experience, negotiation skills, issue resolution, policy and law understanding, matrix organization representation
Technologies
Electronic Regulatory Information Management 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, support policy development, ensure regulatory compliance and data accuracy
Seniority
Director, strategic leadership and team management