Executive Director, Regulatory Strategy, Cell & Gene Therapy Job at Vertex Pharmaceuticals, Boston, MA

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  • Vertex Pharmaceuticals
  • Boston, MA

Job Description

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.

Responsibilities

  • 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

Requirements

  • 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

Compensation: $268,200 - $402,200

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