Senior Director, Regulatory CMC — Lead NDA & Global Submissions

Regulatory Jobs; Boston (MA); On-site; USD 175,000 - 260,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision insurance

Life insurance

Paid time off

Health and wellness program

Job summary

Centessa Pharmaceuticals, a Boston-based clinical-stage company, seeks a Senior Director, Regulatory CMC to lead regulatory CMC strategies across small molecule programs, from preclinical to NDA readiness.

Reporting to the Executive Director, you will oversee submissions (INDs, NDAs), manage CDMOs, ensure cGMP compliance, and guide cross-functional teams toward timely regulatory approvals. This role requires 12+ years in pharma with 5+ years in Regulatory CMC and US leadership with travel.

Qualifications

• Bachelor level not accepted; advanced degree required or preferred.
• Minimum 12 years in pharma with 5+ years Regulatory CMC.
• Direct NDA/IND experience and global health authority interactions.

Responsibilities

• Lead integrated Regulatory CMC strategies for small molecules.
• Provide strategic leadership across development, manufacturing, and QC.
• Serve as CMC expert on cross-functional teams and programs.
• Guide regulatory risk assessment and lifecycle planning.
• Oversee preparation/review of CMC content for submissions.
• Monitor global regulatory changes and ensure readiness.
• Manage CDMOs including tech transfer and scale-up.
• Ensure cGMP compliance and inspection readiness.

Skills

Regulatory CMC leadership

Project management

Cross-functional collaboration

Strategic regulatory thinking

Team leadership

FDA/ICH knowledge

Outsourced manufacturing

Education

Master's in Chemistry or related field

PharmD or PhD preferred

Regulatory CMC experience (12+ yrs)

Job description

Centessa Pharmaceuticals, a Boston-based clinical-stage company, seeks a Senior Director, Regulatory CMC to lead regulatory CMC strategies across small molecule programs, from preclinical to NDA readiness.

Reporting to the Executive Director, you will oversee submissions (INDs, NDAs), manage CDMOs, ensure cGMP compliance, and guide cross-functional teams toward timely regulatory approvals. This role requires 12+ years in pharma with 5+ years in Regulatory CMC and US leadership with travel.