Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy

Job Title: Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy

Available locations:

• Gaithersburg, MD
• Boston, MA
• South San Francisco, CA
• Santa Monica, CA

Introduction to role: Are you ready to set the global regulatory vision for pioneering cell and gene therapies and turn breakthrough science into real options for patients?

This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling.

You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients.

You will report to the Executive Director, Cell and Gene Therapy Regulatory Affairs and act as a franchise global regulatory lead for programs with multiple indications, with the opportunity to serve in a dual capacity as a regional lead based on your expertise. Working across discovery through commercialization, you will partner closely with Global Product Teams to align science, evidence and policy, while coaching a Global Regulatory Strategy Team to deliver at the highest level.

Could you be the strategic voice that anticipates risk, seizes expedited opportunities and influences the dialogue with global health authorities?

Accountabilities:

Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. -

Franchise and Regional Responsibility: Serve as global regulatory lead for complex, multi-indication programs and, where relevant, take on regional leadership to integrate region-specific strategy and execution.

Health Authority Strategy and Engagement: Lead strategy for agency meetings, information requests and expedited pathway designations; drive robust preparation that secures clear outcomes and de-risks pivotal milestones.

Dossier and Labeling Excellence: Direct the planning and construction of the global dossier and core prescribing information; own target product labeling strategy and negotiation readiness.

Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.

Evidence and Decision-Making: Continuously assess emerging data against program aspirations; present risks, trade-offs and mitigations to senior leadership to enable decisive, >

Date Posted

24-Jun-2026

Closing Date

14-Jul-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.