Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy
$276,127–$414,190 year
Hybrid · Boston, Massachusetts, United States or Gaithersburg, Maryland, United States
Job Summary
Executive Director, Regulatory Affairs Strategy for Cell and Gene Therapy responsible for owning end-to-end global regulatory strategy from discovery through BLA submission and lifecycle management. Build and lead Regulatory Strategy Teams; influence policy and guidance; engage major health authorities; shape target product labeling; ensure timely approvals and lifecycle enhancement across indications and modalities. Role requires advanced degree in science with 10+ years of regulatory experience in cell/gene therapy, proven cross-functional leadership, and ability to operate in a matrix organization with strategic, enterprise-wide impact.
Required Qualifications
- Advanced degree in a science-related field
- At least ten or more years of experience in regulatory strategy with cell and/or gene therapy
- Demonstrated success in global regulatory strategy and health authority engagement
- Experience leading cross-functional teams and coaching regulatory talent
- Strong understanding of global regulatory science and product development processes across modalities
- Proven ability to influence policy and provide strategic regulatory guidance at senior levels
- Excellent oral, written, and presentation skills; strong organizational capabilities
- Ability to work in a fast-paced environment and manage multiple initiatives
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