Global Regulatory Submissions Director

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 163,200 - 244,800; Full time

Job summary

Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle programs, including Pulmonary or Cell & Gene Therapy areas. You will partner with Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising & Promotion to ensure timely, compliant submissions and data integrity.

This role requires 7+ years in regulatory submission management, strong project management

Qualifications

• Strong knowledge of global regulatory submission requirements, processes, and timelines.
• Experience with submission and project management tools and systems.
• Ability to manage multiple concurrent submissions and competing priorities.
• Strong organizational, planning, and problem-solving skills.
• Effective stakeholder management and cross-functional communication skills.

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.
• 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.
• Escalates risks appropriately when submissions approach higher-impact or higher-complexity thresholds.
• Leads, coaches, and supports submission management staff including vendor functional service providers (FSPs).
• Contributes to continuous improvement, knowledge sharing, and talent development within submission management.

Skills

Regulatory submissions

Project management

Stakeholder management

Cross-functional communication

Regulatory strategy

Education

Bachelor’s degree in Life Sciences, Regulatory Affairs, Project Management, or a related discipline

Tools

MS Project

Smartsheet

Veeva RIM

Job description

Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle programs, including Pulmonary or Cell & Gene Therapy areas. You will partner with Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising & Promotion to ensure timely, compliant submissions and data integrity.

This role requires 7+ years in regulatory submission management, strong project management