Global Director, Regulatory Programs - Oncology Submissions

Socket.dev; Palo Alto (CA); On-site; USD 203,000 - 253,000; Full time

Job summary

Summit Therapeutics Inc. in Miami, FL, seeks a Director of Regulatory Program Management to lead strategic regulatory filings and ensure timely submissions across the product portfolio.

This role drives alignment across Regulatory Affairs, Medical Writing, and Program Leadership to deliver executable plans and governance as the organization scales. The Director partners with executive leadership, mentors Program Managers, and champions continuous improvement of regulatory program management

Qualifications

• Minimum 12 years in regulatory project management within pharma
• Experience leading global, cross-functional regulatory programs
• Solid tumor oncology experience required
• Strong communication with executive leadership

Responsibilities

• Translate regulatory strategy into integrated execution plans
• Lead complex regulatory programs across regions and products
• Coordinate cross-functional teams and governance for filings
• Provide senior leadership with timely status, risks, and decisions
• Mentor and develop Program Managers to strengthen capability

Skills

Regulatory leadership

Cross-functional collaboration

Strategic planning

Executive communication

Education

Bachelor’s degree in science

MS or MBA

PhD/PharmD/DVM with relevant experience

Tools

MS Office

Project

Smartsheet

Job description

Summit Therapeutics Inc. in Miami, FL, seeks a Director of Regulatory Program Management to lead strategic regulatory filings and ensure timely submissions across the product portfolio.

This role drives alignment across Regulatory Affairs, Medical Writing, and Program Leadership to deliver executable plans and governance as the organization scales. The Director partners with executive leadership, mentors Program Managers, and champions continuous improvement of regulatory program management