Executive Director, Regulatory Affairs Strategy - Cell Therapy

Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy

Introduction to role:

• 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:

• Lead and own the development and implementation of the global regulatory strategy for a CGT product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management. May serve in dual-role as Franchise GRL and regional RAD. 

• Represents Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and accountable for all Regulatory activities. 

• Leads regulatory strategy for all major health authority interactions, responses to critical information requests, BLA development and submission, expedited pathway designations, major post-submission interactions, and complex labeling negotiations. 

• Maintains a deep and current working knowledge of the relevant disease areas, evolving scientific evidence, regulatory policy, and external environment. 

• Leads one or more Global Regulatory Strategy Teams (GRST) responsible for specific indications, programs, or franchise-level priorities, and provide leadership, coaching, and performance feedback to members of the GRST and broader matrix teams. 

• Leads the objective executive-level assessment of emerging data against program and portfolio aspirations and update senior management on project risks, mitigation activities, probability of success, and strategic options. 

• Accountable for the delivery of all project-related regulatory milestones, including assessment of the probability of regulatory success, mitigation planning, approval strategy, and lifecycle planning, and lead preparation of regulatory strategy documents and target product labeling. 

• Demonstrate exceptional strategic, leadership, and collaborative skills, contributing to effective cross-functional teamwork and influencing key decisions in product development, franchise strategy, and portfolio prioritization. 

• Lead, participate in, and promote major non-project functional or cross-functional initiatives and engage externally on the corresponding topics as needed. Lead the development and implementation of novel regulatory tools, technologies, and ways of working. 

• Ensure appropriate strategic planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance and compliance activities associated with marketed brands, where applicable. 

• Partner with marketing companies (countries), regional regulatory affairs staff, and senior cross-functional stakeholders to influence developing views, guidance, and regulatory policy interpretation. 

Line management responsibilities of 3-7 regulatory team members in addition to matrixed supervisory, leadership, and mentoring roles, and is expected to contribute to succession planning, capability building, and development of senior regulatory talent. 

Essential Skills/Experience:

• An advanced degree in a science-related field plus leadership experience (able to lead other leaders).
• 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.
• Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology.
• 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.
• Experience working on due diligence activities and in a business alliance environment.
• Experience in leading and growing people through line management, coaching, or mentorship. Contribution to non-project business initiatives at a portfolio, franchise, or enterprise level. Experience contributing to external policy, regulatory science, or industry advocacy initiatives.

Desirable Skills/Experience:

• Experience with product development in oncology, autoimmune, rare diseases, and neurology across multiple indications and modalities.
• Experience working on due diligence activities and in a business alliance environment.
• Experience contributing to external policy, regulatory science, or industry advocacy initiatives.

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

13-Jul-2026

Closing Date

17-Jul-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.