Executive Director, Regulatory Affairs Strategy - Cell Therapy

About this role

Job Title: Executive Director, Regulatory Affairs Strategy - Cell 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 direction for first-in-class cell therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, global patient access? • This role leads the strategy for our most visible and complex cell therapy programs, translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value. • You will work across discovery through commercialization, bringing clarity and pace to decision-making and ensuring our therapies reach patients with unmet needs. • You will directly shape how we engage with health authorities, define target product labeling, and accelerate submissions across multiple indications and modalities. • As a senior leader, you will build capability, coach regulatory talent, and influence policy and guidance to sustain a competitive edge for our pipeline and portfolio.

Accountabilities:

Global Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director.

GPT Representation and Strategic Influence: Represent Regulatory Affairs on Global Product Teams, provide strategic regulatory advice, and be accountable for all regulatory activities that shape development plans, risk management, and commercialization outcomes.

Health Authority Engagement: Lead strategy for major health authority interactions, responses to critical information requests, expedited pathway designations, BLA development and submission, major post-submission interactions, and complex labeling negotiations to secure competitive labels and timely approvals.

External Insight and Policy Shaping : Maintain a deep and current working knowledge of relevant disease areas, evolving scientific evidence, regulatory policy, and the external environment; establish senior external relationships to influence perspectives and maintain competitive advantage.

GRST Leadership and Talent Development: Lead one or more Global Regulatory Strategy Teams focused on indications, programs, or franchise priorities; provide leadership, coaching, and performance feedback; line-manage 3–7 regulatory team members; contribute to succession planning, capability building, and development of senior regulatory talent.

Data-Driven Governance and Risk Management: Deliver objective executive-level assessments of emerging data against program and portfolio aspirations; update senior management on risks, mitigation activities, probability of success, and strategic options.

Milestone Delivery and Dossier Excellence: Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable.

Innovation and Ways of Working: Lead, participate in, and promote major non-project functional or cross-functional initiatives; drive the development and implementation of novel regulatory tools, technologies, and modern ways of working that improve quality and speed.

Cross-Functional and Regional Partnership: Partner with marketing companies, regional regulatory affairs teams, and senior cross-functional stakeholders to influence developing views, guidance, and regulatory policy interpretation; coordinate across therapeutic areas and regulatory teams to deliver our cell therapies to patients.

Essential Skills/Experience : • Bachelor degree in a science-related field and at least ten or more years of experience and/or appropriate knowledge/experience. • Demonstrated extensive success in cell therapy regulatory strategy. • Deep understanding of global regulatory science and integration with program, franchise, and portfolio strategy. • Long-standing experience of overall drug/biologic development processes and strategies for high profile, highly complex, novel, or first-in-class development programs. • Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology. • Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs. • Proven experience leading regulatory and cross-functional teams, influencing senior stakeholders, and operating effectively in complex matrix environments. • Ability to think strategically and critically at enterprise level and evaluate risks to regulatory and business activities. • Previous significant experience in leading Health Authority interaction in major markets. Excellent oral, written, and presentation skills. • Strong organizational skills. Ability to work in a fast-paced environment in a hands-on fashion. • Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities. • Experience working on due diligence activities and in a business alliance environment. • Experience in leading and growing people through line management, coaching, or mentorship. Contribution to non-project business initiatives at a portfolio, franchise, or enterprise level. Experience contributing to external policy, regulatory science, or industry advocacy initiatives.

Desirable Skills/Experience:

• Master's Degree, PhD or MD in a science related field. • Experience with product development in

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