Regulatory Affairs Director
AstraZenecaAbout the role
Regulatory Affairs Director
Oncology R&D
Gaithersburg, MD
Hybrid Work- on average 3 days a week from office
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation, and life cycle management of the assigned cell and gene therapy (CGT) product(s). You'll serve as the global regulatory lead (GRL) on early-stage projects or be responsible for specific indications or jurisdictions of larger programs. You'll have the opportunity to contribute significantly to product and clinical strategy and support cross-functional alignment for governance and health authority interactions. The RAD also serves as the face of the company with Health Authorities.
What you'll do
Accountable for leading the development and implementation of the regional or global regulatory strategy for a CGT product/group of products. Ensures that the strategy is designed for efficient development tailored to the global or specific regional regulatory environment(s), and to deliver approvals aligned to the needs of the business, markets and patients. This includes optimizing the health authority engagement strategy, aligning cross-functionally on messaging, planning the development of submission documents, and driving designation of applicable expedited regulatory programs such as FastTrack, RMAT, Breakthrough, and PRIME.
Lead cross-functional teams in major regulatory submissions (NDA, IND/CTA), Health Authority interactions, label negotiations, and securing NDA/BLA approvals. This includes developing the strategy, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling, and members of the submission and execution team in formulating global regulatory strategy and delivering on NDA filings and approvals
As a regional regulatory lead, the RAD is accountable for providing the region-specific regulatory strategy and direction.
May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and be accountable for all Regulatory activities
Accountable for the delivery of all regulatory milestones on your team including
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