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About the Role
Lead the global regulatory vision for pioneering cell therapies, guiding programs from current stage through licensure with competitive pathways to approval and labeling. Shape strategy for complex programs, bringing clarity, pace, and rigor to accelerate patient access. Report to the Executive Director, Cell Therapy Regulatory Affairs, and serve as a franchise global regulatory lead, with potential for dual regional lead capacity. Partner with Global Product Teams to align science, evidence, and policy, while coaching a Global Regulatory Strategy Team.
Responsibilities
- Own the end-to-end global regulatory strategy for high-complexity cell therapy programs from current stage through BLA submission.
- Ensure an efficient route to approval with competitive labeling aligned to product attributes and patient, market, and business needs.
- Serve as global regulatory lead for complex, multi-indication programs and integrate region-specific strategy and execution.
- Lead strategy for agency meetings, information requests, and expedited pathway designations.
- Drive robust preparation for agency interactions to secure clear outcomes and de-risk pivotal milestones.
- Direct the planning and construction of the global dossier and core prescribing information.
- Own target product labeling strategy and negotiation readiness.
- Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans.
- Contribute to governance presentations and align regulatory objectives with clinical, CMC, safety, and commercial strategies.
- Continuously assess emerging data against program aspirations.
- Present risks, trade-offs, and mitigations to senior leadership for data-driven choices.
- Oversee all regulatory deliverables and milestones, including probability-of-success assessments and contingency planning.
- Lead a Global Regulatory Strategy Team for specific indications/programs.
- Coach, mentor, and manage team members to build capability and performance.
- Build strong relationships with regulatory stakeholders.
- Partner with country and regional regulatory teams to shape developing views and guidance.
- Lead and promote the development of novel regulatory tools and technology.
- Contribute to non-project initiatives that advance work processes and impact.
- Maintain accountability for product maintenance and compliance activities for marketed brands.
Requirements
- A bachelor's degree in a science-related field.
- 7+ years of experience in the regulatory space.
- Demonstrated success in cell therapy regulatory strategy.
- Deep understanding of global regulatory science and integration with program strategy.
- Long-standing experience of overall drug/biologic development processes and strategies for high-profile, complex, or novel development programs.
- Experience with product development in oncology, autoimmune, rare diseases, or neurology.
- Broad background of experience working in the pharmaceutical business.
- Prior experience in several areas within regulatory affairs.
- Proven experience leading regulatory and cross-functional teams.
- Proven stakeholder management experience.
- Ability to think strategically and critically.
- Ability to evaluate risks to regulatory activities.
- Previous experience in leading Health Authority interactions 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.
- Flexibility and proactivity.
- Ability to manage multiple projects and adapt to changing business needs and priorities.
- Successful leadership of at least one global regulatory approval, including leading response teams and labeling negotiations.
Skills
- Cell therapy regulatory strategy
- Global regulatory science
- Drug/biologic development processes
- Oncology
- Autoimmune diseases
- Rare diseases
- Neurology
- Regulatory affairs
- Team leadership
- Stakeholder management
- Strategic thinking
- Critical evaluation
- Risk assessment
- Health Authority interactions
- Oral communication
- Written communication
- Presentation skills
- Organizational skills
- Project management
- Adaptability
- Global regulatory approval leadership
- Response team leadership
- Labeling negotiations
- FDA advisory committee experience
- EMA oral explanation experience
- Due diligence activities
- Business alliance environment experience
- People leadership
- Coaching
- Mentorship
- Contribution to non-project business initiatives
Location
- Gaithersburg, MD
- Boston, MA
- South San Francisco, CA
- Santa Monica, CA
Work Type
- Hybrid
Experience Level
- 7+ years of experience
Education Level
- Bachelor's degree in a science-related field
Salary/Compensations
- $218,058 - $327,087 USD Annual
Benefits
- Short-term incentive bonus opportunity
- Equity-based long-term incentive program
- Retirement contribution
- Commission payment eligibility
- 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
- We unleash bold thinking by bringing unexpected teams together, inspiring life-changing medicines.
- In-person working allows us to connect, work at pace, and challenge perceptions.
- We balance the expectation of being in the office with individual flexibility.
- Join us in our unique and ambitious world.
- Here, your regulatory leadership turns cutting-edge cell therapy science into treatments that change lives—fast.
- We foster a collaborative, empowered environment that blends scientific ambition with practical execution.
- Unexpected teams come together to challenge assumptions, share knowledge across borders, and adopt new technology to shorten development cycles.
- We value kindness alongside ambition, provide autonomy to lead, and offer support to grow.
- We connect your individual impact directly to patients who are waiting.
Equal Opportunity
- We are committed to building an inclusive environment where equal employment opportunities are available to all applicants and employees.
- 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.