Regulatory Strategy Director, Cell & Gene Therapy (Hybrid)

Vertex Pharmaceuticals; Washington (District of Columbia); Hybrid; USD 268.200 - 402.200; Vollzeit

Zusammenfassung

Vertex Pharmaceuticals is seeking an Executive Director, Regulatory Strategy in the Washington, D.C. area to lead global regulatory strategies for Type 1 Diabetes programs.

This role oversees a team of regulatory professionals across regions and is responsible for strategic input to senior cross-functional teams. The role requires deep expertise in regulatory affairs, the ability to drive submissions and communications with health authorities, and a track record of delivering regulatory

Qualifikationen

• Bachelor’s degree in Biology, Chemistry, or other related discipline.
• Typically requires 15 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 7 years of supervisory/management experience, or the equivalent combination of education and experience.

Aufgaben

• Leads the development of regulatory strategy for multiple projects in development (from FIH to post marketing) within the T1D portfolio.
• Ensures global regulatory strategy aligns with corporate objectives and is negotiated with health authorities as appropriate.
• Works with global program leads and regional representatives for unified regulatory input.
• Contributes to review/authorship of regulatory submission documents and health authority communications.
• Counsels senior management on global Regulatory Affairs strategies and practices.
• Manages staff, project plans, and timelines; supports career growth.
• Influences regulatory environment through industry/agency engagement.
• Sponsors continuous improvement of department processes and resource planning.
• May have financial and HR responsibilities for assigned staff.

Kenntnisse

Regulatory strategy

Leadership

Stakeholder management

Regulatory affairs

Cross-functional collaboration

Regulatory submissions

Ausbildung

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

Jobbeschreibung

Vertex Pharmaceuticals is seeking an Executive Director, Regulatory Strategy in the Washington, D.C. area to lead global regulatory strategies for Type 1 Diabetes programs.

This role oversees a team of regulatory professionals across regions and is responsible for strategic input to senior cross-functional teams. The role requires deep expertise in regulatory affairs, the ability to drive submissions and communications with health authorities, and a track record of delivering regulatory