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About the Role

This role leads the strategy for 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 therapies reach patients with unmet needs. You will directly shape health authority engagement, 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.

Responsibilities

Own the end-to-end global regulatory strategy for a cell therapy product or franchise from current stage through BLA submission, approval, and lifecycle management.
Represent Regulatory Affairs on Global Product Teams, provide strategic regulatory advice, and be accountable for all regulatory activities.
Lead strategy for major health authority interactions, responses to critical information requests, expedited pathway designations, BLA development and submission, and complex labeling negotiations.
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.
Lead one or more Global Regulatory Strategy Teams, provide leadership, coaching, and performance feedback.
Line-manage 3–7 regulatory team members and contribute to succession planning and capability building.
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.
Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments and mitigation 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.
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.
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 cell therapies to patients.

Requirements

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 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 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.
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.

Skills

Cell therapy regulatory strategy
Global regulatory science
Drug/biologic development processes
Product development in oncology, autoimmune, rare diseases, neurology
Pharmaceutical business experience
Regulatory affairs
Leading regulatory and cross-functional teams
Influencing senior stakeholders
Complex matrix environments
Strategic and critical thinking
Risk evaluation
Health Authority interaction
Oral communication
Written communication
Presentation skills
Organizational skills
Adaptability
Due diligence
Business alliance
People leadership
Coaching
Mentorship
External policy contribution
Regulatory science contribution
Industry advocacy

Location

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

Work Type

Hybrid

Experience Level

Senior leader
At least ten or more years of experience

Education Level

Advanced degree in a science-related field

Salary/Compensations

$276,000 - $414,000

Benefits

Short-term incentive bonus opportunity
Equity-based long-term incentive program
Qualified retirement program (401(k) plan)
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

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.
We balance the expectation of being in the office while respecting individual flexibility.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
Here, transformative science meets decisive execution. You will help convert cutting-edge cell therapy innovation into globally approved medicines for patients with unmet needs, working in a connected, inclusive environment that values kindness alongside ambition.
We bring diverse experts together to spark bold ideas, apply modern regulatory approaches, and harness data and technology to shorten development cycles.
With a rich pipeline and empowered teams, your leadership will shape labels, accelerate access, and create lasting impact for patients worldwide.

Equal Opportunity

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.