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Executive Director, Regulatory Affairs Strategy - Cell TherapyAstraZeneca · 2 Locations
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AstraZeneca

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Executive Director, Regulatory Affairs Strategy - Cell Therapy

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🗓️ Posted 2026-09-04 2 Locations Full-time Hybrid Healthcare Medical
💰 Salary Not shared 📊 Market 10,000 GBP–16,666 GBP/mo

About the Company

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, global 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: Global 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 devel

Requirements

  • ● An advanced degree in a science-related field and extensive experience at a leadership level.
  • ● Demonstrated extensive success in cell therapy regulatory strategy.
  • ● Deep understanding of global regulatory science and integration with program, franchise, and portfolio strategy.
  • ● Long-standing experience of overall drug/biologic development processes and strategies for high profile, highly complex, novel, or first-in-class development programs.
  • ● Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs.
  • ● Proven experience leading regulatory and cross-functional teams, influencing senior stakeholders, and operating effectively in complex matrix environments.
  • ● Ability to think strategically and critically at enterprise level and evaluate risks to regulatory and business activities.
  • ● Previous significant experience in leading Health Authority interaction in major markets. Excellent oral, written, and presentation skills.
  • ● Strong organizational skills. Ability to work in a fast-paced environment in a hands-on fashion.
  • ● Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.
  • ● When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.
  • ● In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible.
  • ● We balance the expectation of being in the office while respecting individual flexibility.
  • ● Join us in our unique and ambitious world.
  • ● Why AstraZeneca: Here, transformative science meets decisive execution. You will help convert cutting-edge cell therapy innovation into globally approved medicines for patients with unmet needs, working in a connected, inclusive environment that values kindness alongside ambition.
  • ● We bring diverse experts together to spark bold ideas, apply modern regulatory approaches, and harness data and technology to shorten development cycles. With a rich pipeline and empowered teams, your leadership will shape labels, accelerate access, and create lasting impact for patients worldwide.
  • ● Call to Action:
  • ● Step into a role where your regulatory leadership defines the path from discovery to approval-take the lead and shape the future of cell therapy today
  • ● Date Posted 04-Sept-2026
  • ● Closing Date 11-Sept-2026
Credential Requirements for United Kingdom
🔴

PLAB 1 + PLAB 2

General Medical Council

Must have to work
Cost: GBP 1,000–2,000 Timeline: 6–18 months
🔴

NMC CBT + OSCE

Nursing and Midwifery Council

Must have to work
Cost: GBP 1,000–2,000 Timeline: 6–12 months
🔴

GPhC OSPAP

General Pharmaceutical Council

Must have to work
Cost: GBP 6,000–10,000 Timeline: 1 year
🔴

GDC ORE Part 1 + Part 2

General Dental Council

Must have to work
Cost: GBP 2,000–4,000 Timeline: 1–2 years