Director, Regulatory Affairs Strategy - Cell Therapy
About The Position
The Director, Regulatory Affairs Strategy – Cell Therapy will shape and implement global regulatory strategy for complex cell therapy programs across oncology, immune-mediated, and rare diseases. The role guides programs from current development stages through key submission milestones and may support product maintenance activities, with a focus on efficient approval pathways and competitive labeling that reflect product characteristics and business, market, and patient needs. As regulatory lead for a product, indication, or defined program component, the Director will work with senior leaders and global, regional, and country teams. The role includes leading Health Authority engagement strategies, expedited pathway designations, responses to information requests, and BLA development and submission. It also involves assessing emerging data, communicating regulatory risks and mitigations, delivering project milestones, and preparing regulatory strategy documents and target product labeling. The Director will serve as a core member of the Global Product Team and Global Regulatory Strategy Team, collaborate across functions, and contribute to improvements in regulatory processes, tools, and practices. The role includes mentoring and matrix support for less experienced colleagues and may include limited line management responsibilities. The position is based in Gaithersburg, Maryland; Boston, Massachusetts; South San Francisco, California; or Santa Monica, California. The company expects employees to work from the office an average of at least three days per week, while allowing individual flexibility.
Requirements
- Bachelor's degree in a science-related field.
- At least 5 years of regulatory experience; cell therapy experience is strongly preferred.
- Understanding of global regulatory science and its integration with program strategy.
- Extensive experience with overall drug or biologic development processes and strategies for high-profile, complex, or novel development programs.
- Broad pharmaceutical business experience and prior experience in several areas within regulatory affairs.
- Proven experience leading regulatory and cross-functional teams and managing stakeholders.
- Ability to think strategically and critically and evaluate risks to regulatory activities.
- Previous experience leading Health Authority interactions in major markets.
- Excellent oral, written, and presentation skills.
- Strong organizational skills.
- Ability to work hands-on in a fast-paced environment.
- Flexible and proactive approach, with the ability to manage multiple projects and adapt successfully to changing business needs and priorities.
Nice To Haves
- Advanced degree in a science-related field, such as an MSc, PhD, or MD.
- Experience in cell therapy regulatory strategy or related regulatory activities.
- Product development experience in oncology, autoimmune disease, rare diseases, or neurology.
- Experience supporting a global regulatory approval or major submission activity.
- Experience preparing for an FDA advisory committee or EMA oral explanation.
- Experience with due diligence activities or in a business alliance environment.
- Experience mentoring colleagues or contributing to team development.
- Contribution to non-project business initiatives or cross-functional improvement activities.
Responsibilities
- Contribute to and implement global regulatory strategy for a complex cell and gene therapy product or indication through key submission milestones; support product maintenance as needed.
- Serve as regulatory lead for a product, indication, or defined program component, potentially combining global and regional regulatory leadership responsibilities.
- Develop regulatory strategies that support an efficient approval pathway and competitive labeling aligned with product characteristics and business, market, and patient needs; contribute to governance presentations.
- Drive strategy and execution for Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission.
- Maintain disease-area knowledge and lead objective assessments of emerging data against program aspirations; communicate risks and mitigation plans to senior management.
- Support delivery of project-related regulatory milestones, including probability-of-success assessments and mitigation strategies.
- Lead preparation of regulatory strategy documents and target product labeling; support planning and assembly of the global dossier and core prescribing information with relevant teams.
- Participate as a core member of the Global Product Team and Global Regulatory Strategy Team, collaborating to advance development objectives.
- Participate in non-project initiatives to improve regulatory processes, tools, and practices, and foster knowledge sharing across locations and therapy areas.
- Partner with country organizations and regional regulatory colleagues to align on evolving views, local considerations, and regulatory guidance.
- Mentor and provide matrix support to less experienced colleagues; the role may include limited line management responsibilities.
Benefits
- Qualified retirement program (401(k) plan).
- Paid vacation and holidays.
- Paid leaves.
- Medical, prescription drug, dental, and vision coverage.
- Short-term incentive bonus opportunity.
- Eligibility to participate in the equity-based long-term incentive program for salaried roles.
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What This Job Offers
Job Type
Full-time
Career Level
Director
