Director, Global Submission Management
Vertex Pharmaceuticals
August 20, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
The Director, Global Submission Management (GSM) provides strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs, including planning, submission, and closeout, to enable and advance global product registrations.
Key Duties And Responsibilities:
- Oversee a defined portfolio of regulatory submissions from planning through closeout
- Develop and maintain submission plans, timelines, and tracking across multiple programs
- Ensure consistent use of submission management standards, tools, and processes
- Partner with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define scope, milestones, and deliverables
- Coordinate cross-functional activities to ensure completeness, quality, and compliance
- Identify, manage, and resolve operational risks; escalate when thresholds are reached
- Oversee status updates, issue logs, and portfolio-level reporting
- Support workload planning and capacity management
- Lead, coach, and support submission management staff and vendor FSPs
- Drive continuous improvement and knowledge sharing; adopt emerging technologies (incl. AI)
Knowledge And Skills:
- Strong knowledge of global regulatory submission requirements, processes, and timelines
- Experience with submission/project management tools; manage multiple concurrent submissions
- Organizational, problem-solving, and cross-functional stakeholder management skills
Education And Experience:
- Bachelor’s degree in Life Sciences/Regulatory Affairs/Project Management or related field
- 10+ years relevant experience with leadership across submission portfolios
- Experience across routine, regional, and lifecycle submissions; matrixed environments
- People-management experience; MS Project, Smartsheet, Veeva RIM
Pay Range:
- $190,400 - $285,600; eligible for annual bonus and annual equity awards.
The Director, Global Submission Management (GSM) provides strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs, including planning, submission, and closeout, to enable and advance global product registrations.
Key Duties And Responsibilities:
- Oversee a defined portfolio of regulatory submissions from planning through closeout
- Develop and maintain submission plans, timelines, and tracking across multiple programs
- Ensure consistent use of submission management standards, tools, and processes
- Partner with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define scope, milestones, and deliverables
- Coordinate cross-functional activities to ensure completeness, quality, and compliance
- Identify, manage, and resolve operational risks; escalate when thresholds are reached
- Oversee status updates, issue logs, and portfolio-level reporting
- Support workload planning and capacity management
- Lead, coach, and support submission management staff and vendor FSPs
- Drive continuous improvement and knowledge sharing; adopt emerging technologies (incl. AI)
Knowledge And Skills:
- Strong knowledge of global regulatory submission requirements, processes, and timelines
- Experience with submission/project management tools; manage multiple concurrent submissions
- Organizational, problem-solving, and cross-functional stakeholder management skills
Education And Experience:
- Bachelor’s degree in Life Sciences/Regulatory Affairs/Project Management or related field
- 10+ years relevant experience with leadership across submission portfolios
- Experience across routine, regional, and lifecycle submissions; matrixed environments
- People-management experience; MS Project, Smartsheet, Veeva RIM
Pay Range:
- $190,400 - $285,600; eligible for annual bonus and annual equity awards.