Executive Director, Reg Strategy - Gene & Cell Therapy

Regulatory Jobs; Boston (MA); Hybride; USD 268 000 - 402 000; Plein temps

Résumé du poste

Vertex seeks an Executive Director, Regulatory Strategy to lead global regulatory planning for its Type 1 Diabetes portfolio. You will shape cross‑functional strategies, interact with Health Authorities, and guide senior teams in complex regulatory decisions.

This senior role combines strategic vision with hands‑on leadership of a global regulatory group. You will influence program design, ensure alignment with corporate goals, and drive efficient submission processes while mentoring staff and

Qualifications

• Bachelor's degree in Biology, Chemistry, or related discipline.
• 15 years of pharmaceutical/biotech regulatory affairs experience; 7+ years in supervision.

Responsabilités

• Lead development of regulatory strategy for multiple T1D projects from FIH to post-approval.
• Ensure global regulatory strategy aligns with corporate objectives and Health Authority expectations.
• Collaborate with global program leads and regional teams for unified input across development and commercial activities.
• Contribute to writing and review of regulatory submissions and Health Authority communications.
• Mentor staff, manage project plans and resource allocation to meet milestones.
• Represent regulatory leadership in industry conferences and agency meetings.

Connaissances

Regulatory strategy

Global/regional knowledge

Leadership

Communication

Influence

Strategic thinking

Formation

Bachelor's degree in Biology or Chemistry

Description du poste

Vertex seeks an Executive Director, Regulatory Strategy to lead global regulatory planning for its Type 1 Diabetes portfolio. You will shape cross‑functional strategies, interact with Health Authorities, and guide senior teams in complex regulatory decisions.

This senior role combines strategic vision with hands‑on leadership of a global regulatory group. You will influence program design, ensure alignment with corporate goals, and drive efficient submission processes while mentoring staff and