Senior Director, Regulatory Affairs Strategy - Cell Therapy

Available locations:
Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CA Introduction to role:
Are you ready to set the global regulatory vision for pioneering cell 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 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? Global Regulatory Leadership:
Own the end-to-end global regulatory strategy for a high-complexity cell 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, data-driven choices.

Delivery and Milestone Management:
Oversee all regulatory deliverables and milestones, including probability-of-success assessments and contingency planning to protect timelines and value.

Team Leadership and Talent Development:
Lead a Global Regulatory Strategy Team for specific indications/programs; coach, mentor and, as applicable, line-manage team members to build capability and performance.

External Influence and Partnerships:
Build strong relationships with regulatory stakeholders; partner with country and regional regulatory teams to shape developing views and guidance.

Innovation and Tools:
Lead and promote the development of novel regulatory tools and technology, and contribute to non-project initiatives that advance how we work and the impact we deliver.

Marketed Product Stewardship:
Maintain accountability for product maintenance and compliance activities associated with marketed brands, ensuring continued benefit to patients and compliance with evolving requirements. Essential Skills/

Experience:

A bachelors degree in a science related field 7+ years of experience in the regulatory space Demonstrated success in cell therapy regulatory strategy.…