Executive Director, Regulatory Affairs Strategy - Cell Therapy

AstraZeneca · New York City +3 more

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RegulatoryFull-time$276k–$414kCompany career page

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Role summary

AstraZeneca seeks an Executive Director to lead global regulatory strategy for complex cell therapy programs from development through commercialization. This senior role encompasses health authority engagement, team leadership, and cross-functional partnership to advance first-in-class therapies to approval and market access.

What they're looking for

Bachelor's degree in science field; 10+ years relevant experience in cell therapy regulatory strategy
Deep knowledge of global regulatory science integrated with program and portfolio strategy
Extensive experience with high-complexity, novel, or first-in-class drug/biologic development programs
Prior work in oncology, autoimmune, rare diseases, or neurology therapeutic areas
Proven leadership of regulatory and cross-functional teams in complex matrix environments
Significant experience leading health authority interactions in major markets
Advanced degree (Master's, PhD, or MD) preferred

What you'll be doing

Own end-to-end global regulatory strategy for cell therapy product franchises from current stage through BLA submission, approval, and lifecycle management
Represent Regulatory Affairs on Global Product Teams and provide strategic advice shaping development plans and commercialization outcomes
Lead major health authority engagement strategy, including submissions, expedited pathway designations, and labeling negotiations
Line-manage 3–7 regulatory team members, providing coaching, performance feedback, and succession planning contribution
Deliver executive-level data assessments, risk management updates, and probability-of-success evaluations to senior leadership

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