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

Location: Gaithersburg, MD

Introduction to role:

• Are you ready to set the global regulatory direction for first-in-class cell and gene 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 and gene 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 and gene 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:

• An advanced 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 and/or gene 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:

• Experience with product development in oncology, autoimmune, rare diseases, and neurology across multiple indications and modalities.
• Experience working on due diligence activities and in a business alliance environment.
• Experience contributing to external policy, regulatory science, or industry advocacy initiatives.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.

In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible.

We balance the expectation of being in the office while respecting individual flexibility.

Pay transparency

The annual base pay for this position ranges from $ 276,127 - $414,190USD Annual. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position and the

Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Call to Action:

Step into a role where your regulatory leadership defines the path from discovery to approvaltake the lead and shape the future of cell and gene therapy today!

Date Posted

Closing Date