Job Title: Director, Regulatory Affairs Strategy - Cell Therapy
Available locations:
Barcelona, Spain
Amsterdam, Netherlands
Introduction to role:
Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients?
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 information requests, expedited pathway designations, and BLA development and submission.
Data-Driven Decision-Making: Maintain stron

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