Regulatory Strategy Director — Cell & Gene Therapy

Vertex Pharmaceuticals LLC; United States; Hybrid; USD 268,000 - 402,000; Full time

Job summary

Vertex Pharmaceuticals is seeking an Executive Director, Regulatory Strategy to lead global regulatory planning for the Type 1 Diabetes portfolio and to guide complex submissions from first-in-human to post-approval milestones.

The role manages a global/regional team, shapes strategic regulatory input for cross-functional programs, mentors staff, and partners with health authorities to deliver timely, compliant regulatory outcomes in a fast-paced biopharma environment.

Qualifications

• 15+ years in regulatory affairs within the pharma/biotech industry
• 7+ years of supervisory/management experience
• Experience with regulatory submissions and health authority communications

Responsibilities

• Lead regulatory strategy development for multiple T1D projects from FIH to post-marketing stages
• Coordinate input from global/regional teams to align development, clinical and commercial plans
• Advise senior management on regulatory tactics and milestones
• Mentor staff and manage resources to ensure timely, compliant deliverables

Skills

Regulatory strategy

Regulatory affairs leadership

Global regulatory knowledge

Cross-functional leadership

Education

Bachelor's degree in Biology or Chemistry

Job description

Vertex Pharmaceuticals is seeking an Executive Director, Regulatory Strategy to lead global regulatory planning for the Type 1 Diabetes portfolio and to guide complex submissions from first-in-human to post-approval milestones.

The role manages a global/regional team, shapes strategic regulatory input for cross-functional programs, mentors staff, and partners with health authorities to deliver timely, compliant regulatory outcomes in a fast-paced biopharma environment.