Executive Director – Regulatory Affairs Strategy, Cell Therapy

AstraZeneca

Executive Director leading global regulatory strategy for first-in-class cell therapies. Influencing policy, guiding submissions, and ensuring access to patients with unmet needs.

Posted 7/18/2026full-timeGaithersburg • California, Maryland, Massachusetts • 🇺🇸 United StatesLead💰 $276,000 - $414,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in global regulatory strategy for cell therapy products, with a strong background in drug and biologic development processes. Proven ability to lead cross-functional teams and engage with health authorities while maintaining a deep understanding of relevant disease areas and regulatory policies.

Highest-signal resume keywords

Cell Therapy Regulatory StrategyGlobal Regulatory ScienceDrug/Biologic Development ProcessesLeadership of Regulatory TeamsCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentDossier ConstructionHealth Authority InteractionsOncology Product DevelopmentAutoimmune Disease KnowledgeRare Disease ExpertiseNeurology Product Development

Soft Skills

Excellent Oral CommunicationStrong Written CommunicationPresentation SkillsOrganizational Skills

Certifications & Qualifications

Advanced Degree in Science-Related Field

Industry Keywords

Regulatory AffairsGlobal Product TeamsStrategic PlanningCross-Functional Stakeholders

About the role

Key responsibilities & impact

Own the end-to-end global regulatory strategy for a cell therapy product
Represent Regulatory Affairs on Global Product Teams
Lead strategy for major health authority interactions
Maintain a deep and current working knowledge of relevant disease areas and regulatory policy
Lead one or more Global Regulatory Strategy Teams
Ensure strong strategic planning and construction of the global dossier
Partner with marketing companies and cross-functional stakeholders

Requirements

What you’ll need

An advanced degree in a science-related field
At least ten or more years of experience and/or appropriate knowledge/experience
Demonstrated extensive success in cell therapy regulatory strategy
Deep understanding of global regulatory science
Long-standing experience of drug/biologic development processes and strategies for high profile, highly complex programs
Experience with product development in oncology, autoimmune, rare diseases, neurology
Proven experience leading regulatory and cross-functional teams
Excellent oral, written, and presentation skills
Strong organizational skills

Benefits

Comp & perks

Competitive salary and benefits package
Short-term incentive bonus opportunity
Eligibility to participate in equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
401(k) plan
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage