Executive Director, Regulatory Strategy, Cell & Gene Therapy
Vertex Pharmaceuticals
August 30, 2026
Remote friendly (Washington, DC)
United States
Corporate Functions
General Summary:
- The Executive Director, Regulatory Strategy will oversee development and implementation of innovative global regulatory strategies for product development and commercialization within the T1D portfolio. Manages global/regional regulatory professionals with program leadership responsibilities and shapes cohesive regulatory strategy across programs.
Key Duties and Responsibilities:
- Lead development of regulatory strategy for multiple projects (from first-in-human to post-marketing application) within the T1D portfolio.
- Ensure global regulatory strategy aligns with corporate business objectives and is negotiated with relevant health authorities as appropriate.
- Coordinate unified regulatory input across global/regional teams for development, clinical, and commercial strategy.
- Review, author, and ensure quality of regulatory submission documents and Health Authority communications.
- Counsel senior management on status of global Regulatory Affairs strategies, tactics, procedures, and practices.
- Create/assess project plans and timelines; assign and manage staff; support staff career growth.
- Influence the regulatory environment through participation in conferences, regulatory meetings, committees, and trade associations.
- Sponsor continuous improvement of department processes/strategies; recommend resource planning.
- Serve as a people manager; may have financial and HR responsibilities for assigned staff.
Knowledge and Skills:
- Expert regulatory affairs knowledge (global/regional/local frameworks and guidance for human pharmaceutical development).
- Expertise in R&D, preclinical/clinical requirements for drug development, registration, and maintenance.
- Advanced ability to analyze data, protocols, safety reporting, labeling, and phase activities.
- Experience creating and assessing regulatory authority proposals and leading health authority interactions.
- Ability to navigate ambiguity; agile communication of requirements, opportunities, risks, and alternatives.
- Build and sustain strategic cross-functional partnerships.
- Stay current on scientific/clinical advances and regulatory environment changes.
- Strong leadership, communication (verbal/written), and matrix leadership.
Education and Experience:
- Bachelor’s degree in Biology, Chemistry, or related discipline.
- Typically 15 years in regulatory affairs within pharma/biotech and 7 years supervisory/management experience (or equivalent).
Pay/Benefits (as stated):
- Annual base salary range: $268,200 - $402,200; eligible for annual bonus and annual equity awards.
Application Instructions:
- Not specified.
- The Executive Director, Regulatory Strategy will oversee development and implementation of innovative global regulatory strategies for product development and commercialization within the T1D portfolio. Manages global/regional regulatory professionals with program leadership responsibilities and shapes cohesive regulatory strategy across programs.
Key Duties and Responsibilities:
- Lead development of regulatory strategy for multiple projects (from first-in-human to post-marketing application) within the T1D portfolio.
- Ensure global regulatory strategy aligns with corporate business objectives and is negotiated with relevant health authorities as appropriate.
- Coordinate unified regulatory input across global/regional teams for development, clinical, and commercial strategy.
- Review, author, and ensure quality of regulatory submission documents and Health Authority communications.
- Counsel senior management on status of global Regulatory Affairs strategies, tactics, procedures, and practices.
- Create/assess project plans and timelines; assign and manage staff; support staff career growth.
- Influence the regulatory environment through participation in conferences, regulatory meetings, committees, and trade associations.
- Sponsor continuous improvement of department processes/strategies; recommend resource planning.
- Serve as a people manager; may have financial and HR responsibilities for assigned staff.
Knowledge and Skills:
- Expert regulatory affairs knowledge (global/regional/local frameworks and guidance for human pharmaceutical development).
- Expertise in R&D, preclinical/clinical requirements for drug development, registration, and maintenance.
- Advanced ability to analyze data, protocols, safety reporting, labeling, and phase activities.
- Experience creating and assessing regulatory authority proposals and leading health authority interactions.
- Ability to navigate ambiguity; agile communication of requirements, opportunities, risks, and alternatives.
- Build and sustain strategic cross-functional partnerships.
- Stay current on scientific/clinical advances and regulatory environment changes.
- Strong leadership, communication (verbal/written), and matrix leadership.
Education and Experience:
- Bachelor’s degree in Biology, Chemistry, or related discipline.
- Typically 15 years in regulatory affairs within pharma/biotech and 7 years supervisory/management experience (or equivalent).
Pay/Benefits (as stated):
- Annual base salary range: $268,200 - $402,200; eligible for annual bonus and annual equity awards.
Application Instructions:
- Not specified.