Senior Director, Regulatory Strategy
Vertex Pharmaceuticals
August 22, 2026
Remote friendly (Washington, DC)
United States
Corporate Functions
Key Duties & Responsibilities
- Lead development of regulatory strategy for multiple/complex development projects (first-in-human to post-marketing), including regulatory submission documents and Health Authority communications.
- Represent Global Regulatory Affairs (GRA) on core/project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
- Address complex regulatory issues; provide guidance to cross-functional teams; counsel senior management on global Regulatory Affairs strategies, tactics, procedures, and practices.
- Develop and manage project plans/timelines; assign/manage resources to prioritize work and meet goals on time.
- Influence regulatory environment via conferences, industry/agency regulatory meetings, committees, and trade associations; stay current on regulations, policy, intelligence, and competitive issues.
- Lead continuous improvement of department processes/strategies.
- Lead GRA functional team(s); coach, develop, and provide performance feedback.
- People management may include financial and HR responsibilities for assigned staff.
Required Knowledge & Skills
- Business-minded strategic leader; innovative solutions to regulatory problems.
- Excellent communication skills; ability to influence decisions; present and document regulatory strategy.
- Regulatory leadership in cross-functional, matrix environments.
- Deep expertise in regulatory affairs science and global/regional/local frameworks for human pharmaceutical development (research & development, preclinical/clinical, registration, maintenance).
- Advanced data/protocol/safety reporting/labeling interpretation across drug development phases.
- Expertise in proposing regulatory paths and clinical plans; lead productive Health Authority interactions.
- Ability to assess regulatory pathway adequacy and guide refinements based on regulatory outcomes.
- Ability to align with strategic vision/core values; improve internal regulatory policies/programs.
- Cultural sensitivity; embraces diversity; mentors and develops staff.
Required Education & Experience
- Bachelor’s degree in Biology, Chemistry, or related discipline.
- Typically 12 years’ relevant pharmaceutical/biotech regulatory affairs experience and 5 years’ supervisory/management experience (or equivalent).
Application
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for hiring-process accommodations.
- Lead development of regulatory strategy for multiple/complex development projects (first-in-human to post-marketing), including regulatory submission documents and Health Authority communications.
- Represent Global Regulatory Affairs (GRA) on core/project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
- Address complex regulatory issues; provide guidance to cross-functional teams; counsel senior management on global Regulatory Affairs strategies, tactics, procedures, and practices.
- Develop and manage project plans/timelines; assign/manage resources to prioritize work and meet goals on time.
- Influence regulatory environment via conferences, industry/agency regulatory meetings, committees, and trade associations; stay current on regulations, policy, intelligence, and competitive issues.
- Lead continuous improvement of department processes/strategies.
- Lead GRA functional team(s); coach, develop, and provide performance feedback.
- People management may include financial and HR responsibilities for assigned staff.
Required Knowledge & Skills
- Business-minded strategic leader; innovative solutions to regulatory problems.
- Excellent communication skills; ability to influence decisions; present and document regulatory strategy.
- Regulatory leadership in cross-functional, matrix environments.
- Deep expertise in regulatory affairs science and global/regional/local frameworks for human pharmaceutical development (research & development, preclinical/clinical, registration, maintenance).
- Advanced data/protocol/safety reporting/labeling interpretation across drug development phases.
- Expertise in proposing regulatory paths and clinical plans; lead productive Health Authority interactions.
- Ability to assess regulatory pathway adequacy and guide refinements based on regulatory outcomes.
- Ability to align with strategic vision/core values; improve internal regulatory policies/programs.
- Cultural sensitivity; embraces diversity; mentors and develops staff.
Required Education & Experience
- Bachelor’s degree in Biology, Chemistry, or related discipline.
- Typically 12 years’ relevant pharmaceutical/biotech regulatory affairs experience and 5 years’ supervisory/management experience (or equivalent).
Application
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for hiring-process accommodations.