Senior Director, Regulatory Affairs Strategy – Cell Therapy

• Set the global regulatory vision for pioneering cell therapies
• Own the end-to-end global regulatory strategy for high-complexity cell therapy programs
• Lead strategy for agency meetings, information requests, and expedited pathway designations
• Shape development and commercialization plans
• Oversee all regulatory deliverables and milestones
• Build strong relationships with regulatory stakeholders
• Lead a Global Regulatory Strategy Team for specific indications/programs
• Maintain accountability for product maintenance and compliance activities

Requirements

• An advanced degree in a science related field
• 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
• Experience with product development in oncology, autoimmune, rare diseases, neurology
• Proven experience leading regulatory and cross-functional teams
• Excellent oral, written, and presentation skills
• Strong organizational skills
• Ability to work in a fast-paced environment

Core Competencies

Expertise in global regulatory strategy for cell therapies, with a strong focus on compliance, product development, and cross-functional team leadership. Proven ability to navigate complex regulatory environments and build relationships with stakeholders in the biotechnology sector.

Highest-signal resume keywords

• Cell Therapy Regulatory Strategy
• Global Regulatory Science
• Drug/Biologic Development Processes
• Regulatory Team Leadership
• Cross-Functional Collaboration

Hard Skills

• Regulatory Strategy Development
• Regulatory Deliverables Oversight
• Product Maintenance Compliance
• Agency Meeting Strategy
• Expedited Pathway Designation

Soft Skills

• Excellent Oral Communication
• Strong Organizational Skills
• Presentation Skills

Certifications & Qualifications

• Advanced Degree in Science

Industry Keywords

• Oncology
• Autoimmune Diseases
• Rare Diseases
• Neurology
• Regulatory Stakeholder Engagement