Executive Director, Regulatory Strategy, Cell & Gene Therapy

$268.2k - $402.2k

Vertex Pharmaceuticals

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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Vacancy posted 5 days ago

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