Executive Director, Regulatory Strategy, Cell & Gene Therapy
Vertex Pharmaceuticals
August 08, 2026
Remote friendly (Washington, DC)
United States
Corporate Functions
General Summary:
- The Executive Director, Regulatory Strategy will oversee development and implementation of global regulatory strategies for product development and commercialization within the T1D portfolio. Manages global/regional regulatory professionals and shapes cohesive regulatory strategy across programs.
Key Duties And Responsibilities:
- Lead regulatory strategy development for multiple T1D projects from FIH through post-marketing application stages.
- Ensure global regulatory strategy aligns with corporate business objectives and is negotiated with relevant health authorities as appropriate.
- Coordinate unified regulatory input with global program leads and regional representatives across development, clinical, and commercial teams.
- Review, author, and ensure quality of regulatory submission documents and Health Authority communications.
- Counsel senior management on Regulatory Affairs strategy/tactics, procedures, and practices.
- Create/assess project plans and timelines; assign/manage staff; prioritize work and meet key goals; support staff career growth.
- Influence the regulatory environment via conferences, industry/agency regulatory meetings, committees, and trade associations.
- Sponsor continuous improvement of department processes/strategies; provide resource planning recommendations.
Knowledge And Skills:
- Expertise in regulatory affairs science and global/regional/local regulatory frameworks for pharmaceutical development.
- Advanced knowledge of R&D, preclinical/clinical requirements, drug registration, and maintenance.
- Strong skills in analyzing/interpreting data, protocols, safety reporting, and labeling.
- Advanced ability to create and assess regulatory path/clinical plan proposals and lead health authority interactions.
- Ability to navigate ambiguity; strategic thinking; excellent written/verbal communication; strong matrix leadership.
Education And Experience:
- Bachelor’s degree in Biology, Chemistry, or related field.
- Typically 15 years of relevant pharmaceutical/biotech regulatory affairs experience and 7 years supervisory/management experience (or equivalent).
- The Executive Director, Regulatory Strategy will oversee development and implementation of global regulatory strategies for product development and commercialization within the T1D portfolio. Manages global/regional regulatory professionals and shapes cohesive regulatory strategy across programs.
Key Duties And Responsibilities:
- Lead regulatory strategy development for multiple T1D projects from FIH through post-marketing application stages.
- Ensure global regulatory strategy aligns with corporate business objectives and is negotiated with relevant health authorities as appropriate.
- Coordinate unified regulatory input with global program leads and regional representatives across development, clinical, and commercial teams.
- Review, author, and ensure quality of regulatory submission documents and Health Authority communications.
- Counsel senior management on Regulatory Affairs strategy/tactics, procedures, and practices.
- Create/assess project plans and timelines; assign/manage staff; prioritize work and meet key goals; support staff career growth.
- Influence the regulatory environment via conferences, industry/agency regulatory meetings, committees, and trade associations.
- Sponsor continuous improvement of department processes/strategies; provide resource planning recommendations.
Knowledge And Skills:
- Expertise in regulatory affairs science and global/regional/local regulatory frameworks for pharmaceutical development.
- Advanced knowledge of R&D, preclinical/clinical requirements, drug registration, and maintenance.
- Strong skills in analyzing/interpreting data, protocols, safety reporting, and labeling.
- Advanced ability to create and assess regulatory path/clinical plan proposals and lead health authority interactions.
- Ability to navigate ambiguity; strategic thinking; excellent written/verbal communication; strong matrix leadership.
Education And Experience:
- Bachelor’s degree in Biology, Chemistry, or related field.
- Typically 15 years of relevant pharmaceutical/biotech regulatory affairs experience and 7 years supervisory/management experience (or equivalent).