Executive Director, Regulatory Affairs Strategy - Cell Therapy
Core
Lead global regulatory strategy for first-in-class cell therapy programs from discovery through BLA submission and lifecycle management, translating science into approved medicines with competitive labels.
Role type
Executive Director, Regulatory Affairs Strategy (Cell Therapy)
Builds
Global regulatory strategy documents, target product labeling, and dossiers for complex cell therapy franchises.
Domain
Biopharmaceuticals / Cell Therapy / Oncology / Autoimmune / Rare Diseases / Neurology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, BLA development, health authority engagement, team leadership (3-7 direct reports), risk management, cross-functional partnership, policy influence, strategic planning
Preferred skills
Master's/PhD/MD in science, oncology/autoimmune/rare disease/neurology expertise, due diligence experience, industry advocacy
Technologies
Regulatory submission tools, dossier construction platforms
Responsibilities
Own end-to-end global regulatory strategy for complex cell therapy programs; represent Regulatory Affairs on Global Product Teams; lead major health authority interactions and labeling negotiations; build and coach regulatory teams; deliver executive-level risk assessments and milestone plans; drive innovation in regulatory ways of working.
Seniority
Executive Director, hands-on IC with line management responsibilities