Executive Director, Regulatory Affairs Strategy - Cell Therapy

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

• 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.

:

• 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 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.