Global Regulatory Program Lead for Submissions

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

Job summary

Summit Therapeutics Inc. seeks a Director, Regulatory Program Management to lead strategic regulatory filings across its oncology portfolio.

You will align with Research, Development, Regulatory Affairs, and Manufacturing to deliver complex submissions and ensure program success. You will partner with senior leadership to translate portfolio strategies into executable plans, govern processes, and advance regulatory execution across regions.

Qualifications

• Bachelor's degree and 12+ years of regulatory project management/scientific experience; OR an MS/MBA with 10+ years; OR a PhD/PharmD/DVM with 6+ years.
• Prior solid tumor oncology experience required.
• Significant experience leading complex, global regulatory programs.
• Demonstrated experience with major regulatory submissions and health‑authority interactions.
• Experience with senior stakeholders and matrixed organizations.

Responsibilities

• Translate regulatory strategy into integrated execution plans with leadership.
• Lead planning and execution of complex, high‑visibility regulatory programs across regions and products.
• Chair efficient cross‑functional meetings to coordinate operations and decisions.
• Integrate cross‑functional workstreams across Research, Development, Regulatory Affairs and Manufacturing.
• Define milestones, timelines, and decision points for regulatory programs.
• Assess risks, identify opportunities, and communicate status to senior leadership.

Skills

Regulatory program management

Cross-functional leadership

Communication

Strategic planning

Education

Bachelor's degree in a scientific/regulated field

MS/MBA and 10+ years experience

PhD/PharmD/DVM with 6+ years experience

Tools

MS Office

MS Project

Smartsheet

Job description

Summit Therapeutics Inc. seeks a Director, Regulatory Program Management to lead strategic regulatory filings across its oncology portfolio.

You will align with Research, Development, Regulatory Affairs, and Manufacturing to deliver complex submissions and ensure program success. You will partner with senior leadership to translate portfolio strategies into executable plans, govern processes, and advance regulatory execution across regions.