Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Barcelona, SpainAmsterdam, NetherlandsIntroduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients?Todos los candidatos deben asegurarse de leer atentamente la siguiente descripción del puesto y la información antes de enviar su solicitud.In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases—translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets. You will join a high-performing, cross-functional environment where regulatory insight is central to program decision-making. Partnering with senior leaders and global teams, you will lead strategy across key milestones—from expedited designations and Health Authority interactions through major submissions and post-approval maintenance—helping the business deliver transformative therapies at pace and with rigor.



Can you see yourself guiding a complex program from pivotal data through approval and beyond while keeping patient value and global needs front and center?Accountabilities: Integral Regulatory Strategy: Contribute to and implement the global regulatory strategy for a complex CGT product or indication from current stage through key submission milestones; support product maintenance activities as needed.Program Leadership: Serve as regulatory lead for a product, indication, or defined program component; may serve in a dual role as Global Regulatory Lead and regional regulatory lead. Approval Path and Labeling: Ensure regulatory strategies enable an efficient path to approval with competitive labeling aligned to product characteristics and business, market, and patient needs; contribute to governance presentations.Health Authority Engagements: Drive strategy and execution for Health Authority meetings, responses to

📌 Director, Regulatory Affairs Strategy (Barcelona)
🏢 AstraZeneca
📍 Barcelona