Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy
Job Title: Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy
Available locations:
Barcelona, SpainAmsterdam, 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 submission, ma

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