Regulatory Strategy Executive Director, Cell & Gene Therapy

Vertex Pharmaceuticals Inc (US); United States; Híbrido; USD 268.000 - 402.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity awards

Generous paid time off

Commuting subsidy

401(k)

Descripción de la vacante

Vertex Pharmaceuticals is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategies for the Type 1 Diabetes portfolio. You will oversee a team of regulatory professionals, work with cross-functional development teams, and influence regulatory pathways and submissions to support product development and commercialization.

The role emphasizes senior leadership, strategic input, and collaboration across functions to ensure alignment with corporate objectives and

Formación

• Bachelor's degree required in Biology, Chemistry, or related discipline.
• 15 years of relevant pharmaceutical or biotech regulatory affairs experience.
• 7 years of Supervisory/management experience or equivalent combination.

Responsabilidades

• Leads development of regulatory strategy for multiple projects within Type 1 Diabetes portfolio from FIH to post marketing.
• Ensures global regulatory strategy aligns with corporate objectives and negotiates with health authorities as appropriate.
• Collaborates with global/regional teams to provide unified regulatory input into development programs and commercial strategy.
• Contributes to review and quality of regulatory submission documents and health authority communications.
• Counsels senior management on status of regulatory strategies, procedures and practices.
• Manages staff and resources to prioritize projects and meet key milestones.
• Influences regulatory environment through participation in conferences and industry/regulatory meetings.

Educación

Bachelor's degree in Biology, Chemistry, or related discipline

Descripción del empleo

Vertex Pharmaceuticals is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategies for the Type 1 Diabetes portfolio. You will oversee a team of regulatory professionals, work with cross-functional development teams, and influence regulatory pathways and submissions to support product development and commercialization.

The role emphasizes senior leadership, strategic input, and collaboration across functions to ensure alignment with corporate objectives and