Senior Director, Regulatory Affairs Strategy – Cell and Gene Therapy

AstraZeneca

Global regulatory lead managing high-complexity cell and gene therapy programs at AstraZeneca. Shaping regulatory strategies and ensuring product access for patients.

Posted 6/19/2026full-timeGaithersburg • Maryland, Massachusetts • 🇺🇸 United StatesSenior💰 $218,058 - $327,087 per yearWebsite

About the role

Key responsibilities & impact

Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program
Serve as global regulatory lead for complex, multi-indication programs
Lead strategy for agency meetings, information requests and expedited pathway designations
Direct the planning and construction of the global dossier and core prescribing information
Represent Regulatory Affairs on Global Product Teams
Continuously assess emerging data against program aspirations
Oversee all regulatory deliverables and milestones
Lead a Global Regulatory Strategy Team for specific indications/programs
Build strong relationships with regulatory stakeholders
Lead and promote the development of novel regulatory tools and technology
Maintain accountability for product maintenance and compliance activities associated with marketed brands

Requirements

What you’ll need

An advanced degree in a science related field and seven to ten years of experience and/or appropriate knowledge/experience
Demonstrated success in cell and/or gene therapy regulatory strategy
Deep understanding of global regulatory science and integration with program strategy
Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs
Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
Proven experience leading regulatory and cross-functional teams, and stakeholder management
Ability to think strategically and critically and evaluate risks to regulatory activities
Previous experience in leading Health Authority interactions 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
Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations

Benefits

Comp & perks

short-term incentive bonus opportunity
eligibility to participate in our equity-based long-term incentive program (salaried roles)
retirement contribution (hourly roles)
commission payment eligibility (sales roles)
qualified retirement program (401(k) plan)
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage

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Hard Skills & Tools

regulatory strategycell therapygene therapydrug development processesbiologic developmentregulatory deliverablesexpedited pathway designationsglobal dossier constructionregulatory compliancestakeholder management

Soft Skills

strategic thinkingcritical evaluationoral communicationwritten communicationpresentation skillsorganizational skillsflexibilityproactivityproject managementteam leadership