Executive Director, Regulatory Strategy, Cell & Gene Therapy
Vertex Pharmaceuticals · Boston, MA +1 more
RegulatoryFull-time$268k–$402kCompany career page
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Role summary
Vertex Pharmaceuticals seeks an experienced regulatory leader to develop and implement global regulatory strategies for Type 1 Diabetes programs. This executive role manages a team of regulatory professionals across multiple development stages and represents regulatory input on senior cross-functional teams.
What they're looking for
- Bachelor's degree in Biology, Chemistry, or related discipline
- 15 years pharmaceutical or biotech regulatory affairs industry experience
- 7 years supervisory or management experience in regulatory environment
- Expert knowledge of global regulatory frameworks and health authority procedures
- Advanced expertise in clinical trial design and drug development requirements
- Demonstrated ability to lead health authority interactions and regulatory negotiations
- Strong strategic thinking and cross-functional leadership capabilities
What you'll be doing
- Lead regulatory strategy development for multiple Type 1 Diabetes programs from early development through post-marketing stages
- Manage team of global and regional regulatory professionals with program oversight responsibilities
- Ensure portfolio regulatory strategies align with corporate objectives and health authority requirements
- Provide regulatory counsel to senior management on strategic affairs, procedures, and practices
- Oversee staff development, project planning, and resource allocation for regulatory initiatives
Privacy & handoff
This role links to Vertex Pharmaceuticals's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.