Director, Regulatory Affairs Strategy - Cell Therapy

About the role

Steer global regulatory strategy for cell therapies that redefine standards of care for patients. Shape the regulatory path for programs spanning oncology, immune-mediated, and rare diseases, translating breakthrough science into timely approvals and competitive labeling.

Responsibilities

• Contribute to and implement the global regulatory strategy for a complex CGT product or indication from current stage through key submission milestones; support product maintenance activities as needed.
• Serve as regulatory lead for a product, indication, or defined program component; may serve in a dual role as Global Regulatory Lead and regional regulatory lead.
• Ensure regulatory strategies enable an efficient path to approval with competitive labeling aligned to 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 strong disease area knowledge; lead objective assessments of emerging data versus program aspirations; communicate risks and mitigation plans to senior management.
• Support delivery of all 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 the respective teams.
• Operate as a core member of the Global Product Team and Global Regulatory Strategy Team, demonstrating strong strategic, communication, and collaboration skills to advance development objectives.
• Participate in non-project initiatives to enhance regulatory processes, tools, and practices; 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.
• Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities.

Requirements

An advanced degree in a science related field and typically five to eight years of experience and/or appropriate knowledge/experience. 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. 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.

Qualifications

• Experience in cell therapy regulatory strategy or related regulatory activities.
• Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology.
• Experience supporting a global regulatory approval or major submission activity.
• Experience with FDA advisory committee or EMA oral explanation preparation.
• Experience working on 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.

Skills

• Strategic thinking and critical evaluation of regulatory activities.
• Strong communication and collaboration skills.
• Ability to manage multiple projects and adapt to changing business needs.
• Experience in leading Health Authority interactions in major markets.
• Excellent oral, written, and presentation skills.
• Strong organizational skills.

Benefits

• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage