Director, Global Regulatory Submissions (Hybrid)

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 190,400 - 285,600; Full time

Job summary

Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and lifecycle programs, aligning with regulatory strategies and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising & Promotion.

You will supervise submission management staff and vendor partners, drive continuous improvement, and leverage modern tooling like MS Project, Smartsheet, and Veeva RIM in a hybrid work environment.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Project Management, or related field.
• 10+ years of leadership across submission portfolios.
• Experience managing routine, regional, and lifecycle submissions across multiple regions.
• Experience working in matrixed, cross-functional environments.
• People-management experience.
• Experience using MS Project, Smartsheet, and Veeva RIM.

Responsibilities

• Provides oversight for a defined portfolio of regulatory submissions, from planning through submission and closeout.
• Develops and maintains submission plans, timelines, and tracking across multiple programs.
• Ensures consistent application of submission management standards, tools, and processes.
• Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables.
• Coordinates cross-functional activities to ensure submission completeness, quality, and compliance.
• Identifies, manages, and resolves operational risks affecting submission timelines or quality.
• Oversees preparation of submission status updates, issue logs, and portfolio-level reporting.
• Supports workload planning and capacity management across the submission portfolio.

Skills

Regulatory submissions

Cross-functional coordination

Project management

Regulatory strategy

Vendor management

Education

Bachelor’s degree in Life Sciences or related field

Tools

MS Project

Smartsheet

Veeva RIM

Job description

Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and lifecycle programs, aligning with regulatory strategies and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising & Promotion.

You will supervise submission management staff and vendor partners, drive continuous improvement, and leverage modern tooling like MS Project, Smartsheet, and Veeva RIM in a hybrid work environment.