Senior Director, Regulatory Affairs Strategy - Cell Therapy
About the job
What you'll do
Lead global regulatory strategy for complex, multi-indication cell therapy programs from development through approval, including health authority engagement, dossier preparation, labeling, and milestone management. Represent Regulatory Affairs on global product teams, guide and develop regulatory strategy teams, and oversee marketed product compliance and external partnerships.
What they're looking for
Requires a science-related bachelor's degree, at least seven years of regulatory experience, demonstrated cell therapy strategy expertise, and a record of leading global regulatory approvals and health authority interactions. Candidates should bring experience with complex drug or biologic development, cross-functional and team leadership, strong communication and organizational skills, and the ability to manage risks and changing priorities.