Available locations:
- Barcelona, Spain
- Amsterdam, Netherlands
Introduction to role: Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough science into real options for patients?
This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling.
You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients.
You will report to the Executive Director, Cell Therapy Regulatory Affairs and act as a franchise integral regulatory lead for programs with multiple indications, with the opportunity to serve in a dual capacity as a regional lead based on your expertise. Working across discovery through commercialization, you will partner closely with Global Product Teams to align science, evidence and policy,
while coaching a Global Regulatory Strategy Team to deliver at the highest level.
Could you be the strategic voice that anticipates risk, seizes expedited opportunities and influences the dialogue with global health authorities?
Accountabilities:
Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. -
Franchise and Regional Responsibility: Serve as global regulatory lead for complex, multi-indication programs and, where relevant, take on regional leadership to integrate region-specific strategy and execution.
Health Authority Strategy and Engagement: Lead strategy for agency meetings, information requests and expedited pathway designations; drive robust preparation that secures clear outcomes and de-ri