Senior Director, Regulatory Affairs Strategy – Cell Therapy

AstraZeneca

. Set the global regulatory vision for pioneering cell therapies .

Posted 9/20/2026full-timeUnited StatesSenior💰 $218,058 - $327,087 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in global regulatory strategy for cell therapies, with a strong focus on leading complex programs through BLA submission and health authority interactions. Proven ability to align regulatory objectives with clinical and commercial strategies while mentoring and managing cross-functional teams.

Highest-signal resume keywords

Global Regulatory StrategyCell Therapy Regulatory StrategyHealth Authority InteractionsRegulatory Affairs LeadershipDrug/Biologic Development Processes

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentBLA SubmissionProduct Development in OncologyRegulatory Dossier PlanningLabeling NegotiationRisk AssessmentRegulatory ComplianceStakeholder ManagementRegulatory Tools DevelopmentCross-Functional Team Leadership

Soft Skills

Strategic ThinkingCritical EvaluationExcellent CommunicationOrganizational SkillsAdaptability

Industry Keywords

Cell TherapiesOncologyAutoimmune DiseasesRare DiseasesNeurologyPharmaceutical BusinessRegulatory ScienceFDAEMAGlobal Product Teams

About the role

Key responsibilities & impact

Set the global regulatory vision for pioneering cell therapies
Lead high-impact programs across cancer, immune-mediated, and rare diseases from current stage through licensure
Own end-to-end global regulatory strategy for complex cell therapy programs through BLA submission
Serve as global regulatory lead for complex, multi-indication programs and potentially as a regional lead
Lead health authority meeting strategy, information requests, and expedited pathway designations
Direct global dossier and core prescribing information planning and construction
Own target product labeling strategy and negotiation readiness
Represent Regulatory Affairs on Global Product Teams and shape development and commercialization plans
Align regulatory objectives with clinical, CMC, safety, and commercial strategies
Assess emerging data and present risks, trade-offs, and mitigations to senior leadership
Oversee regulatory deliverables, milestones, probability-of-success assessments, and contingency planning
Lead, coach, mentor, and potentially line-manage Global Regulatory Strategy Team members
Build relationships with regulatory stakeholders and partner with country and regional regulatory teams
Lead development of novel regulatory tools and technology
Contribute to non-project initiatives that advance organizational impact
Maintain accountability for marketed product maintenance and compliance activities

Requirements

What you’ll need

A bachelors degree in a science related field
7+ years of experience in the regulatory space
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 and strategies for high profile, complex or novel development programs
Experience with product development in oncology, autoimmune, rare diseases, and neurology
Broad 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 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 adapt to changing business needs and priorities
Successful leadership of at least one global regulatory approval, including leading response team and labeling negotiations
Experience with FDA advisory committee and/or EMA oral explanation
Experience working on due diligence activities and in a business alliance environment
Experience leading and growing people through coaching or mentorship
Contribution to non-project business initiatives

Benefits

Comp & perks

Short-term incentive bonus opportunity
Eligibility to participate in equity-based long-term incentive program
Qualified retirement program (401(k) plan)
Paid vacation and holidays
Paid leaves
Medical, prescription drug, dental, and vision coverage
Flexible working arrangement alongside an average minimum of three days per week in the office