Associate Director, Regulatory Starting Materials Strategy

Socket.dev; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Centessa Pharmaceuticals seeks an Associate Director, Regulatory Starting Material to lead strategy and justification for RSM in drug substance manufacturing, aligning with ICH Q11 and global guidance. You will partner with Process Chemistry, Analytical Development, and Regulatory Affairs to defend RSM strategies through health authority interactions and regulatory submissions.

The role requires 8–10 years in CMC or drug substance development, strong leadership, and a track record of regulatory

Qualifications

• 8-10 years of relevant experience in CMC, process chemistry or drug substance/API development/manufacturing
• Demonstrated leadership of starting material or CMC regulatory strategy programs
• Experience supporting late-stage clinical and/or commercial drug substance programs
• Deep working knowledge of ICH Q11 and regional guidance governing RSM selection
• Experience authoring and defending CMC regulatory submission content and health authority interactions
• Strong background in synthetic/process chemistry and route evaluation

Responsibilities

• Lead identification, justification, and regulatory strategy for Regulatory Starting Materials
• Manage resupply campaigns, inventory, forecasting, and scheduling
• Author and review CMC regulatory submission content for INDs/NDAs/MAAs
• Lead health authority interactions and prepare briefing packages
• Collaborate with Process Chemistry and Analytical Development on routes and impurity risk
• Define GMP/non-GMP boundary for drug substance processes and CMOs
• Lead tech transfer and process changes affecting RSM designation
• Oversee relationships with CMOs and raw material suppliers
• Monitor evolving regulatory guidance and update internal templates
• Collaborate with Regulatory Affairs, Quality, Supply Chain, and Manufacturing to ensure readiness and continuity
• Support due diligence and regulatory inspections/audits
• Build, lead, and mentor RSM/CMC strategy team
• Travel approximately 10–20%

Skills

Regulatory strategy

Cross-functional collaboration

Scientific writing

Leadership

Risk assessment

Health authority interactions

Project management

CMC regulatory submissions

Education

Advanced degree in chemistry, chemical engineering, or related field

PhD strongly preferred

Job description

Centessa Pharmaceuticals seeks an Associate Director, Regulatory Starting Material to lead strategy and justification for RSM in drug substance manufacturing, aligning with ICH Q11 and global guidance. You will partner with Process Chemistry, Analytical Development, and Regulatory Affairs to defend RSM strategies through health authority interactions and regulatory submissions.

The role requires 8–10 years in CMC or drug substance development, strong leadership, and a track record of regulatory