Senior Director, Regulatory Affairs Strategy - Cell Therapy
Core
Lead global regulatory strategy for high-complexity cell therapy programs (cancer, immune-mediated, rare diseases) from discovery through BLA submission, ensuring efficient approval pathways and competitive labeling.
Role type
Senior Director, Regulatory Strategy (Cell Therapy)
Builds
Global regulatory dossiers, prescribing information, and approval pathways for cell therapy products.
Domain
Biopharmaceuticals / Cell Therapy / Oncology / Autoimmune / Rare Diseases
Required skills
Global regulatory strategy, BLA submission, Health Authority engagement, dossier construction, labeling strategy, cross-functional product leadership, team leadership, risk assessment, therapeutic area expertise (oncology/autoimmune/rare diseases/neurology), drug development lifecycle knowledge.
Preferred skills
FDA advisory committee/EMA oral hearing experience, due diligence in business alliances, portfolio-level business initiatives.
Technologies
Regulatory tools and technology development.
Responsibilities
Own end-to-end global regulatory strategy for complex programs; serve as franchise global regulatory lead and regional lead; lead strategy for agency meetings and expedited pathways; direct planning and construction of global dossiers; represent Regulatory Affairs on Global Product Teams; assess emerging data and present risks to senior leadership; oversee regulatory deliverables and milestones; lead and mentor a Global Regulatory Strategy Team; build relationships with regulatory stakeholders; promote novel regulatory tools; maintain accountability for marketed product compliance.
Seniority
Senior Director, hands-on IC with team leadership