Regulatory CMC Senior Director - Biologics Strategy

Summit Therapeutics; United States; Remote; USD 220,000 - 275,000; Full time

Job summary

Summit Therapeutics Inc. seeks a Senior Director, Regulatory Affairs, CMC to lead global regulatory strategies for Summit products, from development through lifecycle management.

This role partners with Manufacturing, Analytical, Supply Chain and Quality to align CMC plans with company goals and lead cross-functional teams in complex regulatory submissions. The candidate will provide hands-on leadership for INDs, IMPDs and BLAs/MAAs, ensure compliance, and drive readiness for inspections, with

Qualifications

• 15+ years Regulatory CMC experience or related pharma industry experience
• Experience in biologics
• Knowledge of FDA, EU and global regulations
• Experience in developing regulatory strategy for complex products and CMC submissions (INDs, BLAs/MAAs)
• Proficiency in Mandarin Chinese is highly desirable

Responsibilities

• Develop CMC regulatory strategies for biologics at all development stages
• Provide strategic and operational regulatory direction on CMC globally
• Lead CMC content authoring, review, and approval of regulatory submissions (INDs, IMPDs, BLAs/MAAs)
• Lead regulatory CMC activities for commercial manufacturing and inspection readiness
• Serve as regulatory CMC lead in health authority meetings and interactions

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory CMC

Education

Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science

Master’s/Ph.D. preferred

Job description

Summit Therapeutics Inc. seeks a Senior Director, Regulatory Affairs, CMC to lead global regulatory strategies for Summit products, from development through lifecycle management.

This role partners with Manufacturing, Analytical, Supply Chain and Quality to align CMC plans with company goals and lead cross-functional teams in complex regulatory submissions. The candidate will provide hands-on leadership for INDs, IMPDs and BLAs/MAAs, ensure compliance, and drive readiness for inspections, with