Senior Director, Regulatory Affairs Strategy - Cell Therapy
AstraZeneca · Gaithersburg, MD +3 more
RegulatoryFull-time$218k–$327kCompany career page
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Role summary
Senior Director leading global regulatory strategy for cell therapy programs across oncology, immunology, and rare diseases at AstraZeneca. This role spans strategy development from current stage through BLA submission, cross-functional product leadership, and health authority engagement to accelerate patient access.
What they're looking for
- Bachelor's degree in science-related field
- 7+ years regulatory affairs experience with demonstrated cell therapy strategy success
- Deep knowledge of global regulatory science and drug/biologic development for complex programs
- Experience in oncology, autoimmune, rare disease, or neurology therapeutic areas
- Proven track record leading global regulatory approvals and health authority negotiations
- Leadership experience with regulatory and cross-functional teams and stakeholder management
- Strong strategic thinking, critical evaluation, and risk assessment capabilities
What you'll be doing
- Own end-to-end global regulatory strategy for complex cell therapy programs from current stage through BLA submission
- Lead health authority strategy, agency meetings, and expedited pathway designation efforts
- Direct global dossier planning, core prescribing information, and target product labeling strategy
- Represent Regulatory Affairs on Global Product Teams and shape development and commercialization plans
- Lead and mentor Global Regulatory Strategy Team for assigned indications and programs
Privacy & handoff
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