Senior Director, Regulatory Affairs Strategy - Cell Therapy
Core
Lead global regulatory strategy for high-complexity cell therapy programs (oncology, autoimmune, rare diseases) from current stage through BLA submission, ensuring efficient approval pathways and competitive labeling.
Role type
Senior Director, Regulatory Strategy (Cell Therapy)
Builds
Global regulatory dossiers, core prescribing information, and target product labeling for cell therapy products.
Domain
Biopharmaceuticals / Cell Therapy / Oncology / Autoimmune / Rare Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, BLA submission experience, Health Authority engagement, dossier construction, labeling negotiation, cross-functional product leadership, team leadership, risk assessment, strategic decision-making
Preferred skills
FDA advisory committee/EMA oral hearing experience, due diligence in business alliances, portfolio-level business initiatives
Technologies
Regulatory tools and technology for strategy and execution
Responsibilities
Own end-to-end global regulatory strategy; lead agency meetings and expedited pathway designations; direct global dossier and labeling planning; represent Regulatory Affairs on Global Product Teams; assess emerging data for decision-making; oversee regulatory deliverables and milestones; lead and mentor a Global Regulatory Strategy Team; build relationships with regulatory stakeholders; maintain accountability for marketed product compliance
Seniority
Senior Director, strategic leadership with hands-on execution