Director, Global Submissions Strategy (Hybrid/Remote)

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 190,000 - 286,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Medical benefits

Commuting subsidy

Job summary

Vertex Pharmaceuticals is seeking a Director, Global Submission Management to lead a portfolio of regulatory submissions across development and lifecycle programs. You will partner with strategy, CMC, labeling, publishing, and advertising to drive efficient, compliant submissions globally.

The role requires 10+ years in regulatory submissions with matrixed leadership, strong planning, and risk management skills, and a focus on continuous improvement using emerging technologies and AI-driven

Qualifications

• Experience leading multiple submissions across regions.
• Strong knowledge of global regulatory timelines.
• Experience with project management tools and regulatory submission tooling.
• People-management experience in a matrixed environment.

Responsibilities

• Oversee portfolio of regulatory submissions from planning through closeout.
• Develop submission plans, timelines, and tracking across programs.
• Ensure compliance with submission standards and processes.
• Coordinate with strategy, CMC, labeling, publishing, and promotion teams.
• Coach and develop submission management staff and vendors.

Skills

Regulatory submissions

Global strategy

Project management

Stakeholder management

Risk management

Regulatory affairs

Education

Bachelor's degree

Tools

MS Project

Smartsheet

Veeva RIM

Job description

Vertex Pharmaceuticals is seeking a Director, Global Submission Management to lead a portfolio of regulatory submissions across development and lifecycle programs. You will partner with strategy, CMC, labeling, publishing, and advertising to drive efficient, compliant submissions globally.

The role requires 10+ years in regulatory submissions with matrixed leadership, strong planning, and risk management skills, and a focus on continuous improvement using emerging technologies and AI-driven