Regulatory Starting Materials Strategy Lead

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

401(k) plan

Medical/Dental/Vision/Life insurance

Generous paid time off

Wellness program

Job summary

Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company, is seeking a Senior Advisor, Regulatory Starting Material to lead strategy, justification, and regulatory positioning for Regulatory Starting Materials in drug substance manufacturing for late-stage programs.

The role partners with Process Chemistry, Analytical Development, Regulatory Affairs, and external CMOs to ensure sound, regulatorily defensible RSM strategies and successful health authority interactions.

Qualifications

• Advanced degree in chemistry, chemical engineering, or a related field; PhD strongly preferred.
• 10+ years in CMC, process chemistry or drug substance/API development and manufacturing with leadership.
• Experience supporting late-stage clinical or commercial drug substance programs.
• Deep knowledge of ICH Q11 and regional guidance governing regulatory starting materials.
• Experience authoring CMC submissions and health authority interactions.

Responsibilities

• Identify and justify regulatory starting materials across drug substance routes per ICH Q11.
• Manage starting material resupply, inventory, forecasting, and scheduling.
• Author/ review Module 3 CMC content and briefing documents.
• Lead health authority interactions and prepare briefing packages.
• Collaborate with Process Chemistry and Analytical Development on routes and impurities.
• Define non-GMP vs GMP boundaries for drug substance steps.
• Lead tech transfer and changes affecting RSM designation.
• Manage CMOs and raw material supplier relationships.
• Monitor regulatory guidance and translate to internal strategy.
• Support due diligence and regulatory inspections related to drug substance.
• Build and mentor RSM/CMC team; travel 10–20%.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Scientific writing

Health authority interactions

Regulatory submissions

Education

PhD in chemistry or related field

Job description

Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company, is seeking a Senior Advisor, Regulatory Starting Material to lead strategy, justification, and regulatory positioning for Regulatory Starting Materials in drug substance manufacturing for late-stage programs.

The role partners with Process Chemistry, Analytical Development, Regulatory Affairs, and external CMOs to ensure sound, regulatorily defensible RSM strategies and successful health authority interactions.