Executive Director – Regulatory Affairs Strategy, Cell Therapy

Responsibilities

• Own the end-to-end global regulatory strategy for a cell therapy product
• Represent Regulatory Affairs on Global Product Teams
• Lead strategy for major health authority interactions
• Maintain a deep and current working knowledge of relevant disease areas and regulatory policy
• Lead one or more Global Regulatory Strategy Teams
• Ensure strong strategic planning and construction of the global dossier
• Partner with marketing companies and cross‑functional stakeholders

Requirements

• An advanced degree in a science‑related field
• At least ten or more years of experience and/or appropriate knowledge/experience
• Demonstrated extensive success in cell therapy regulatory strategy
• Deep understanding of global regulatory science
• Long‑standing experience of drug/biologic development processes and strategies for high profile, highly complex programs
• 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

Core Competencies

Expertise in global regulatory strategy for cell therapy products, with a strong background in drug and biologic development processes. Proven ability to lead cross‑functional teams and engage with health authorities while maintaining a deep understanding of relevant disease areas and regulatory policies.

Highest‑signal resume keywords

• Cell Therapy Regulatory Strategy
• Global Regulatory Science
• Drug/Biologic Development Processes
• Leadership of Regulatory Teams
• Cross‑Functional Collaboration

ATS Optimization Keywords

• Regulatory Strategy Development
• Dossier Construction
• Health Authority Interactions
• Oncology Product Development
• Autoimmune Disease Knowledge
• Rare Disease Expertise
• Neurology Product Development

• Excellent Oral Communication
• Strong Written Communication
• Presentation Skills
• Organizational Skills

• Advanced Degree in Science‑Related Field

• Regulatory Affairs
• Global Product Teams
• Strategic Planning
• Cross‑Functional Stakeholders