Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy
Job Title: Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy
Available locations:
- Barcelona, Spain
- Amsterdam, Netherlands

Introduction to role:
- Are you ready to set the global regulatory direction for first-in-class cell and gene therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, global patient access?
- This role leads the strategy for our most visible and complex cell and gene 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:
Global Regulatory Strategy Leadership: Own the end‐to‐end integral regulatory strategy for a cell and gene 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

📌 Executive Director, Regulatory Affairs Strategy (Laza)
🏢 AstraZeneca
📍 Laza