Strategic Regulatory Leader — Starting Materials

Eli Lilly and Company; Indiana; On-site; USD 153,000 - 268,000; Full time

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks a Senior Advisor, Regulatory Starting Material to lead strategy for drug substance starting materials in late-stage programs. You will partner with Process Chemistry, Analytical Development, Regulatory Affairs, Quality, and CMOs to ensure regulatorily defensible RSM decisions.

The role requires deep expertise in ICH Q11, GMP considerations, and the ability to communicate complex technical issues with health

Qualifications

• Advanced degree required in chemistry, chemical engineering, or related field.
• 7+ years in CMC, process chemistry or drug substance/API development/manufacturing with leadership in regulatory strategy.

Responsibilities

• Lead regulatory strategy for Regulatory Starting Materials across routes per ICHQ11.
• Manage resupply campaigns, inventory, forecasting, and schedule changes.
• Author/review CMC submission content related to RSM for INDs/NDAs/MAAs.

Skills

Leadership

Regulatory strategy

CMC regulatory writing

Cross-functional collaboration

Communication skills

Education

PhD in Chemistry/related field

Advanced degree in chemistry or chemical engineering

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks a Senior Advisor, Regulatory Starting Material to lead strategy for drug substance starting materials in late-stage programs. You will partner with Process Chemistry, Analytical Development, Regulatory Affairs, Quality, and CMOs to ensure regulatorily defensible RSM decisions.

The role requires deep expertise in ICH Q11, GMP considerations, and the ability to communicate complex technical issues with health