Regulatory Strategy Executive – Cell & Gene Therapy (Hybrid)

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 268,200 - 402,200; Full time

Benefits offered by this job

Annual bonus

Annual equity awards

Hybrid-Eligible or On-Site

Job summary

Vertex Pharmaceuticals is seeking an Executive Director of Regulatory Strategy for its Cell & Gene Therapy portfolio focused on Type 1 Diabetes. This global leadership role manages a team of regulatory professionals and drives innovative strategies for development and commercialization.

A strong track record in pharmacovigilance, submissions, and health authority interactions is essential, with hybrid work options available.

Qualifications

• Bachelor's degree required in Biology, Chemistry, or related discipline.
• 15+ years in pharmaceutical/biotech regulatory affairs; 7+ years in supervision/management.
• Experience leading regulatory strategy for complex programs across development stages.

Responsibilities

• Lead global/regional regulatory strategy for multiple T1D projects from FIH to post-market.
• Coordinate with cross-functional teams to align regulatory plans with corporate objectives.
• Contribute to regulatory submissions, health authority communications, and guidance documents.
• Mentor and develop staff, manage timelines and budget, and optimize processes.

Skills

Regulatory strategy

Drug development

Team leadership

Strategic communication

Health authority liaison

Education

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

Job description

Vertex Pharmaceuticals is seeking an Executive Director of Regulatory Strategy for its Cell & Gene Therapy portfolio focused on Type 1 Diabetes. This global leadership role manages a team of regulatory professionals and drives innovative strategies for development and commercialization.

A strong track record in pharmacovigilance, submissions, and health authority interactions is essential, with hybrid work options available.