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About the Role

Lead high-impact cell therapy programs from current stage through licensure, guiding them with clear, 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 a high-complexity cell therapy program, from current stage through BLA submission, ensuring 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, where relevant, take on regional leadership to integrate region-specific strategy and execution.
Lead strategy for agency meetings, information requests, and expedited pathway designations; drive robust preparation that secures clear outcomes and de-risks 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, contributing to governance presentations, and aligning 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 to enable decisive, data-driven choices.
Oversee all regulatory deliverables and milestones, including probability-of-success assessments and contingency planning to protect timelines and value.
Lead a Global Regulatory Strategy Team for specific indications/programs; coach, mentor, and, as applicable, line-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, and contribute to non-project initiatives that advance how we work and the impact we deliver.
Maintain accountability for product maintenance and compliance activities associated with marketed brands, ensuring continued benefit to patients and compliance with evolving requirements.

Requirements

An advanced degree in a science related field and seven to ten years of experience and/or appropriate knowledge/experience.
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 the following therapeutic areas: oncology, autoimmune, rare diseases, neurology.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
Proven experience leading regulatory and cross-functional teams, and stakeholder management.
Ability to think strategically and critically and 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.
Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.
Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations.
Experience with FDA advisory committee and/or EMA oral explanation.
Experience working on due diligence activities and in a business alliance environment.
Experience in leading and growing people through coaching or mentorship.
Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level).

Skills

Cell therapy regulatory strategy
Global regulatory science
Drug/biologic development processes
Oncology
Autoimmune
Rare diseases
Neurology
Pharmaceutical business
Regulatory affairs
Team leadership
Stakeholder management
Strategic thinking
Risk evaluation
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
Business alliance
People leadership
Coaching
Mentorship
Non-project business initiatives

Location

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

Work Type

In-person working
Hybrid

Experience Level

Senior
Seven to ten years of experience

Education Level

Advanced 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.
We work, on average, a minimum of three days per week from the office, balancing in-office expectations with individual flexibility.
Our 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.
We challenge assumptions, share knowledge across borders, and adopt new technology to shorten development cycles.
We value kindness alongside ambition, give autonomy to lead, and provide support to grow.
We connect individual impact directly to patients who are waiting.

Equal Opportunity

We build 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.