Senior Director, Regulatory Affairs Strategy – Cell Therapy

AstraZeneca

Senior Director in Regulatory Affairs Strategy focusing on cell therapies. Leading global regulatory efforts with significant impact on patient access and compliance.

Posted 7/29/2026full-timeGaithersburg • California, Maryland, Massachusetts • 🇺🇸 United StatesSenior💰 $218,058 - $327,087 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in global regulatory strategy for cell therapies, with a strong focus on compliance, product development, and cross-functional team leadership. Proven ability to navigate complex regulatory environments and build relationships with stakeholders in the biotechnology sector.

Highest-signal resume keywords

Cell Therapy Regulatory StrategyGlobal Regulatory ScienceDrug/Biologic Development ProcessesRegulatory Team LeadershipCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Deliverables OversightProduct Maintenance ComplianceAgency Meeting StrategyExpedited Pathway Designation

Soft Skills

Excellent Oral CommunicationStrong Organizational SkillsPresentation Skills

Certifications & Qualifications

Advanced Degree in Science

Industry Keywords

OncologyAutoimmune DiseasesRare DiseasesNeurologyRegulatory Stakeholder Engagement

About the role

Key responsibilities & impact

Set the global regulatory vision for pioneering cell therapies
Own the end-to-end global regulatory strategy for high-complexity cell therapy programs
Lead strategy for agency meetings, information requests, and expedited pathway designations
Shape development and commercialization plans
Oversee all regulatory deliverables and milestones
Build strong relationships with regulatory stakeholders
Lead a Global Regulatory Strategy Team for specific indications/programs
Maintain accountability for product maintenance and compliance activities

Requirements

What you’ll need

An advanced degree in a science related field
Seven to ten years of experience and/or appropriate knowledge/experience
Demonstrated success in cell therapy regulatory strategy
Deep understanding of global regulatory science and integration with program strategy
Long standing experience of overall drug/biologic development processes
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
Ability to work in a fast-paced environment

Benefits

Comp & perks

Health benefits including medical, prescription drug, dental, and vision coverage
Paid vacation and holidays
Paid leaves
Qualified retirement program [401(k) plan]
Short-term incentive bonus opportunity
Eligibility to participate in equity-based long-term incentive program