Director, Regulatory Affairs Strategy - Cell Therapy

Accountabilities

• Global Regulatory Strategy: 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.
• Program Leadership: 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.
• Approval Path and Labeling: 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.
• Health Authority Engagements: Drive strategy and execution for Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission.
• Data-Driven Decision-Making: Maintain strong disease area knowledge; lead objective assessments of emerging data versus program aspirations; communicate risks and mitigation plans to senior management.
• Milestone Delivery: Support delivery of all project-related regulatory milestones, including probability-of-success assessments and mitigation strategies.
• Core Documents and Labeling: 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.
• Cross-Functional Collaboration: 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.
• Process Excellence: Participate in non-project initiatives to enhance regulatory processes, tools, and practices; foster knowledge sharing across locations and therapy areas.
• Country and Regional Alignment: Partner with country organizations and regional regulatory colleagues to align on evolving views, local considerations, and regulatory guidance.
• Team Development: Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities.

Essential Skills/Experience

• 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.
• 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.

Desirable Skills/Experience

• 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.