Global Regulatory Program Director

Regulatory Toolkit; Miami (FL); Hybrid; USD 190,000 - 237,000; Full time

Job summary

Summit Therapeutics Inc. is seeking a Director, Regulatory Program Management to provide strategic and operational leadership for high-priority regulatory filings across the portfolio.

This role aligns Research, Development, Regulatory Affairs, Manufacturing and program teams to deliver clear, rigorous submissions. The Director partners with Regulatory Affairs and Medical Writing to translate strategies into executable plans, maintain governance, and support health-authority interactions.

Qualifications

• Bachelor's degree in life sciences or related field plus 12 years in regulatory project management.
• MS or MBA with at least 10 years of experience in regulatory programs.
• PhD/PharmD/DVM with 6+ years of relevant regulatory experience.

Responsibilities

• Translate regulatory strategy into executable plans with cross-functional teams.
• Lead and manage high-visibility regulatory programs across regions and products.
• Provide governance, dashboards, and executive visibility on program status and risks.

Skills

Regulatory Program Management

Cross-functional Leadership

Strategic Planning

Risk Management

Executive Communication

Education

Bachelor's degree in life sciences

MS or MBA

PhD in scientific field or PharmD or DVM

Tools

MS Office

Microsoft Project

Smartsheet

Job description

Summit Therapeutics Inc. is seeking a Director, Regulatory Program Management to provide strategic and operational leadership for high-priority regulatory filings across the portfolio.

This role aligns Research, Development, Regulatory Affairs, Manufacturing and program teams to deliver clear, rigorous submissions. The Director partners with Regulatory Affairs and Medical Writing to translate strategies into executable plans, maintain governance, and support health-authority interactions.