Global Regulatory Program Director - Strategy & Submissions

Summit Therapeutics; Palo Alto (CA); On-site; USD 203,000 - 253,000; Full time

Job summary

Summit Therapeutics seeks a Director of Regulatory Program Management to lead high-priority regulatory filings across the portfolio. The role aligns Research, Development, Regulatory Affairs, and Manufacturing to deliver rigorous, timely submissions and clear governance across programs.

The position partners with Regulatory Affairs, Medical Writing, and leadership to translate strategies into executable plans and drive organizational capability in complex regulatory initiatives.

Qualifications

• Bachelor’s degree and minimum 12 years of regulatory project management/scientific experience; or MS/MBA with 10+ years; or PhD/PharmD/DVM with 6+ years.
• Prior solid tumor oncology experience required.
• Significant experience leading complex, global regulatory programs and submissions.
• Experience interacting with health authorities and senior stakeholders; strong communication and governance skills.

Responsibilities

• Translate regulatory strategy into executable plans across functions and regions.
• Lead planning and execution of complex regulatory programs with cross-functional teams.
• Chair efficient meetings to coordinate decisions and communications.
• Ensure adherence to regulatory filing timelines and governance models.
• Provide senior leadership with visibility into status, risks, and milestones.
• Mentor Program Managers and strengthen organizational capability.

Skills

Project management

Communication

Facilitation

Organizational skills

Education

Bachelor’s degree or higher in a scientific field

Tools

MS Office

Project

Smartsheet

Job description

Summit Therapeutics seeks a Director of Regulatory Program Management to lead high-priority regulatory filings across the portfolio. The role aligns Research, Development, Regulatory Affairs, and Manufacturing to deliver rigorous, timely submissions and clear governance across programs.

The position partners with Regulatory Affairs, Medical Writing, and leadership to translate strategies into executable plans and drive organizational capability in complex regulatory initiatives.