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Director, Regulatory Affairs Strategy – Cell and Gene Therapy
AstraZenecaDirector of Regulatory Affairs Strategy overseeing global regulatory strategy for therapies at AstraZeneca. Leading multidisciplinary teams to drive approvals and maintain regulatory standards.
Posted 6/19/2026full-timeGaithersburg • Maryland, Massachusetts • 🇺🇸 United StatesLead💰 $186,232 - $279,349 per yearWebsite
About the role
Key responsibilities & impact- Steer global regulatory strategy for cell and gene therapies
- Shape the regulatory path for oncology, immune-mediated, and rare disease programs
- Lead strategy across key milestones from expedited designations to post-approval maintenance
- Drive strategy and execution for Health Authority meetings and responses
- Maintain strong disease area knowledge and lead objective assessments
- Support delivery of all project-related regulatory milestones
- Lead preparation of regulatory strategy documents and target product labeling
- Operate as a core member of Global Product Team and Global Regulatory Strategy Team
- Foster knowledge sharing across locations and therapy areas
- Provide mentoring to less experienced colleagues
Requirements
What you’ll need- An advanced degree in a science-related field
- Five to eight years of experience or appropriate knowledge/experience
- Understanding of global regulatory science and integration with program strategy
- Proven experience leading regulatory and cross-functional teams
- 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
- Flexible and proactive with multiple projects
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 our equity-based long-term incentive program
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
regulatory strategyregulatory scienceproject-related regulatory milestonesregulatory strategy documentstarget product labelingHealth Authority interactionsoncologyimmune-mediated diseasesrare diseases
Soft Skills
mentoringorganizational skillscommunication skillspresentation skillsleadershipflexibilityproactivityteam collaborationknowledge sharing
Certifications
advanced degree in a science-related field