Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy

Available locations:
- Barcelona, Spain
- Amsterdam, Netherlands

Introduction to role:
- Are you ready to set the global regulatory direction for first-in-class cell therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, general patient access?
- This role leads the strategy for our most visible and complex cell therapy programs, translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value.
- You will work across discovery through commercialization, bringing clarity and pace to decision-making and ensuring our therapies reach patients with unmet needs.
- You will directly shape how we engage with health authorities, define target product labeling, and accelerate submissions across multiple indications and modalities.
- As a senior leader, you will build capability, coach regulatory talent, and influence policy and guidance to sustain a competitive edge for our pipeline and portfolio.





Accountabilities:

Integral Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director.

GPT Representation and Strategic Influence: Represent Regulatory Affairs on Global Product Teams, provide strategic regulatory advice, and be accountable for all regulatory activities that shape development plans, risk management, and commercialization outcomes.

Health Authority Engagement: Lead strategy for major health authority interactions, responses to critical information requests, expedited pathway designations, BLA development and submission, major post-submission interactions, and complex labeling negotiations to secure competitive

📌 Executive Director, Regulatory Affairs Strategy (Barcelona)
🏢 Es10 Az Farmacéutica Spain S.A
📍 Barcelona