Senior Advisor, Regulatory Starting Materials Strategy

Centessa Pharmaceuticals; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

401(k)

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Generous PTO

Wellness Program

Job summary

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

Reporting to the VP, CMC, this role serves as the SME on RSM selection, ensuring GMP routes and supply strategies are regulatorily defensible.

Qualifications

• Advanced degree in chemistry, chemical engineering, or related field; PhD strongly preferred.

Responsibilities

• Lead identification, justification, and regulatory strategy for Regulatory Starting Materials in drug substance routes.

Skills

Regulatory Strategy

CMC Regulatory

Team Leadership

Stakeholder Management

Regulatory Submissions

Process Chemistry

Regulatory Affairs

GMP Knowledge

Education

PhD in Chemistry

Advanced Degree in Chemistry/Engineering

Job description

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

Reporting to the VP, CMC, this role serves as the SME on RSM selection, ensuring GMP routes and supply strategies are regulatorily defensible.