Director, Regulatory Affairs Strategy – Cell Therapy

AstraZeneca

. Contribute to and implement global regulatory strategy for complex CGT products or indications through key submission milestones .

Posted 9/20/2026full-timeUnited StatesLead💰 $186,232 - $279,349 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in global regulatory strategy for complex CGT products, with a strong focus on leading regulatory submissions, managing Health Authority interactions, and developing competitive labeling. Proven ability to mentor colleagues and enhance regulatory processes while navigating the complexities of drug development.

Highest-signal resume keywords

Regulatory Strategy DevelopmentHealth Authority InteractionsCell Therapy ExperienceCross-Functional Team LeadershipRisk Assessment and Mitigation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsGlobal Regulatory ScienceDrug Development ProcessesRegulatory AffairsApproval PathwaysTarget Product LabelingDossier AssemblyProject ManagementStakeholder ManagementRegulatory Documentation

Soft Skills

Strategic ThinkingCritical EvaluationExcellent CommunicationOrganizational SkillsAdaptability

Industry Keywords

Cell TherapyBiologicsPharmaceutical BusinessRegulatory ProcessesGlobal Product Strategy

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Contribute to and implement global regulatory strategy for complex CGT products or indications through key submission milestones
Support product maintenance activities
Serve as regulatory lead for a product, indication, or defined program component
Develop efficient approval pathways and competitive labeling aligned with product, business, market, and patient needs
Drive Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission
Assess emerging data against program aspirations and communicate risks and mitigation plans to senior management
Support project-related regulatory milestones, probability-of-success assessments, and mitigation strategies
Lead regulatory strategy documents and target product labeling
Support planning and assembly of global dossiers and core prescribing information
Participate in Global Product and Global Regulatory Strategy teams
Enhance regulatory processes, tools, and practices and foster knowledge sharing
Partner with country organizations and regional regulatory colleagues
Mentor and provide matrix support to less experienced colleagues; may have limited line management responsibilities

Requirements

What you’ll need

Bachelor's degree in a science related field
5+ years of regulatory experience, with a strong preference for cell therapy
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
Broad pharmaceutical business experience 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

Benefits

Comp & perks

Short-term incentive bonus opportunity
Eligibility for equity-based long-term incentive program (salaried roles)
Qualified retirement program (401(k) plan)
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Flexible working arrangement while working an average minimum of three days per week from the office