Senior Director, Regulatory CMC — Global Submissions & Strategy

Centessa Pharmaceuticals; Boston (MA); On-site; USD 175,000 - 260,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Wellness program

Job summary

Centessa Pharmaceuticals is seeking a Senior Director, Regulatory CMC in the US to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs. You will drive regulatory readiness, oversee submissions, and manage external partners to enable timely registrations.

The ideal candidate has 12+ years in pharma with 5+ years in Regulatory CMC, including NDA-enabling activities, and a strong background in outsourced development and manufacturing.

Qualifications

• 12+ years in pharma with 5+ years in Regulatory CMC.
• Experience leading NDA-enabling activities and marketing applications.
• Strong knowledge of small molecule development and cGMP.

Responsibilities

• Develop and execute Regulatory CMC strategies for small molecule programs.
• Provide leadership across drug substance, drug product, analytical development, manufacturing, and control.
• Serve as the Regulatory CMC SME on cross-functional program teams.
• Lead preparation, review, and approval of CMC content for global submissions.
• Oversee external CDMO management and technology transfer.
• Ensure compliance with FDA/EMA/ICH and inspection readiness.

Skills

Regulatory CMC

Leadership

Project management

Cross-functional collaboration

FDA/EMA knowledge

IND/NDAs filings

CDMO management

Education

Master's degree

PhD preferred

Chemistry

Job description

Centessa Pharmaceuticals is seeking a Senior Director, Regulatory CMC in the US to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs. You will drive regulatory readiness, oversee submissions, and manage external partners to enable timely registrations.

The ideal candidate has 12+ years in pharma with 5+ years in Regulatory CMC, including NDA-enabling activities, and a strong background in outsourced development and manufacturing.