Executive Director, Regulatory Affairs Strategy – Cell Therapy

AstraZeneca

. Own the end-to-end global regulatory strategy for a highly complex and strategically important cell therapy product or franchise through BLA submission, approval, and lifecycle management .

Posted 9/24/2026full-timeUnited StatesLead💰 $276,000 - $414,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in global regulatory strategy for cell therapy products, including BLA submission and lifecycle management. Proven ability to lead regulatory teams, influence stakeholders, and navigate complex regulatory environments while maintaining compliance and driving innovative regulatory practices.

Highest-signal resume keywords

Cell Therapy Regulatory StrategyGlobal Regulatory ScienceHealth Authority InteractionRegulatory Team LeadershipDrug/Biologic Development Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BLA SubmissionRegulatory Strategy DocumentsTarget Product LabelingGlobal Dossier ConstructionRegulatory ComplianceRisk EvaluationProject Milestone DeliveryRegulatory Tools DevelopmentOncology Product DevelopmentAutoimmune Disease Regulatory Experience

Soft Skills

Excellent Oral CommunicationStrong Organizational SkillsCritical ThinkingFlexibilityProactive Management

Certifications & Qualifications

Bachelor's Degree in ScienceMaster's Degree in Science (Desirable)PhD in Science (Desirable)MD in Science (Desirable)

Industry Keywords

Pharmaceutical BusinessRegulatory AffairsComplex Matrix EnvironmentsDue Diligence ActivitiesIndustry Advocacy Initiatives

About the role

Key responsibilities & impact

Own the end-to-end global regulatory strategy for a highly complex and strategically important cell therapy product or franchise through BLA submission, approval, and lifecycle management
Represent Regulatory Affairs on Global Product Teams and provide strategic regulatory advice
Lead major health authority interactions, critical information request responses, expedited pathway designations, BLA development and submission, post-submission interactions, and complex labeling negotiations
Maintain current knowledge of disease areas, scientific evidence, regulatory policy, and the external environment
Establish senior external relationships to influence perspectives and maintain competitive advantage
Lead Global Regulatory Strategy Teams and line-manage 3–7 regulatory team members
Provide leadership, coaching, performance feedback, succession planning, capability building, and development of senior regulatory talent
Deliver executive-level assessments of emerging data, risks, mitigation activities, probability of success, and strategic options
Deliver project-related regulatory milestones, approval strategy, lifecycle planning, regulatory strategy documents, target product labeling, and global dossier construction
Oversee maintenance and compliance for marketed brands where applicable
Lead and promote non-project functional or cross-functional initiatives
Drive development and implementation of novel regulatory tools, technologies, and modern ways of working
Partner with marketing companies, regional regulatory affairs teams, and senior cross-functional stakeholders
Coordinate across therapeutic areas and regulatory teams to deliver cell therapies to patients

Requirements

What you’ll need

Bachelor degree in a science-related field and 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 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 oncology, autoimmune, rare diseases, and 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
Master's Degree, PhD or MD in a science related field (desirable)

Benefits

Comp & perks

Short-term incentive bonus opportunity
Eligibility to participate in an equity-based long-term incentive program
Qualified retirement program (401(k) plan)
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Flexible ways of working
Individualized flexibility balancing personal and work commitments