Senior Director, Regulatory Strategy
Vertex Pharmaceuticals
August 21, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Role Overview:
The Regulatory Strategy Senior Director leads the development and implementation of advanced global regulatory strategies for development programs and/or support of registered and marketed products. Shapes cohesive regulatory strategy across assigned programs and translates regulatory, scientific, operational, and business knowledge into effective implementation plans.
Key Duties & Responsibilities:
- Lead regulatory strategy development for multiple/complex development projects (first-in-human to post-marketing) including regulatory submissions and Health Authority communications.
- Represent GRA on core/project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
- Resolve complex regulatory issues; provide advanced solutions and guidance to cross-functional teams; advise senior management on global regulatory strategies/tactics.
- Develop/manage project plans, timelines, and resource assignments; prioritize work to meet key goals on time.
- Influence the regulatory environment via conferences, industry/agency meetings, committees, and trade associations; track changing regulations/policy/intelligence.
- Lead continuous improvement of department processes and strategies.
- Lead GRA functional team(s), including coaching, skill development, and performance feedback.
- People management: may include financial and HR responsibilities for assigned staff.
Required Knowledge & Skills:
- Strategic, business-minded regulatory leadership; innovative problem solving.
- Strong communication and influence skills; ability to present and write regulatory strategy plans/submission documents.
- Cross-functional leadership in a matrix environment.
- Deep technical expertise in regulatory affairs science/frameworks and global/regional/local regulatory requirements for human pharmaceutical development.
- Advanced analysis of data/protocols/safety reporting/labeling across drug development phases.
- Expertise in regulatory authority proposals, regulatory paths/clinical plans, and leading health authority interactions.
- Ability to evaluate adequacy of regulatory pathways/strategies and recommend refinements.
Required Education & Experience:
- Bachelor’s degree in Biology, Chemistry, or related discipline.
- Typically 12 years relevant pharma/biotech regulatory affairs experience and 5 years supervisory/management experience (or equivalent).
The Regulatory Strategy Senior Director leads the development and implementation of advanced global regulatory strategies for development programs and/or support of registered and marketed products. Shapes cohesive regulatory strategy across assigned programs and translates regulatory, scientific, operational, and business knowledge into effective implementation plans.
Key Duties & Responsibilities:
- Lead regulatory strategy development for multiple/complex development projects (first-in-human to post-marketing) including regulatory submissions and Health Authority communications.
- Represent GRA on core/project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
- Resolve complex regulatory issues; provide advanced solutions and guidance to cross-functional teams; advise senior management on global regulatory strategies/tactics.
- Develop/manage project plans, timelines, and resource assignments; prioritize work to meet key goals on time.
- Influence the regulatory environment via conferences, industry/agency meetings, committees, and trade associations; track changing regulations/policy/intelligence.
- Lead continuous improvement of department processes and strategies.
- Lead GRA functional team(s), including coaching, skill development, and performance feedback.
- People management: may include financial and HR responsibilities for assigned staff.
Required Knowledge & Skills:
- Strategic, business-minded regulatory leadership; innovative problem solving.
- Strong communication and influence skills; ability to present and write regulatory strategy plans/submission documents.
- Cross-functional leadership in a matrix environment.
- Deep technical expertise in regulatory affairs science/frameworks and global/regional/local regulatory requirements for human pharmaceutical development.
- Advanced analysis of data/protocols/safety reporting/labeling across drug development phases.
- Expertise in regulatory authority proposals, regulatory paths/clinical plans, and leading health authority interactions.
- Ability to evaluate adequacy of regulatory pathways/strategies and recommend refinements.
Required Education & Experience:
- Bachelor’s degree in Biology, Chemistry, or related discipline.
- Typically 12 years relevant pharma/biotech regulatory affairs experience and 5 years supervisory/management experience (or equivalent).