Regulatory Starting Material Strategy Lead

Eli Lilly; United States; Remote; USD 153,000 - 268,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Health benefits

Vacation benefits

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is seeking a Senior Advisor, Regulatory Starting Material to lead strategy, justification and regulatory positioning for regulatory starting materials across late-stage drug substance programs in the US.

Reporting to CMC leadership, you will collaborate with Process Chemistry, Analytical Development, Regulatory Affairs and CMOs to ensure scientifically sound, regulatorily defensible routes and supply strategies aligned with

Qualifications

• Advanced degree in chemistry or chemical engineering; PhD strongly preferred.
• 7+ years in CMC, process chemistry or drug substance/API development and manufacturing.
• Experience leading starting material or CMC regulatory strategy programs.
• Deep knowledge of ICH Q11 and regional guidance for starting materials.
• Experience authoring and defending CMC submissions with health authority interactions.
• Strong background in synthetic/process chemistry and route evaluation.
• Experience managing CMOs and raw-material suppliers.
• Working knowledge of cGMP in drug substance manufacturing.
• Experience supporting technology transfer from clinical to commercial scale.
• Strong leadership, cross-functional collaboration, and scientific writing.
• Ability to identify starting material-related risks impacting timelines or supply.

Responsibilities

• Lead regulatory strategy for Regulatory Starting Materials across drug substance routes.
• Actively manage starting material resupply campaigns and scheduling.
• Author and review CMC submission content relating to RSM selection and justification.
• Prepare and lead health authority interactions and briefing packages.
• Collaborate with Process Chemistry and Analytical Development on routes and impurity considerations.
• Define boundary between non-GMP and GMP steps for drug substance processes.
• Lead technology transfer and process changes affecting RSM designation.
• Manage relationships with CMOs and RSM suppliers, including oversight.
• Monitor evolving regulatory guidance and update internal templates and risk assessments.
• Coordinate with Regulatory Affairs, Quality, Supply Chain, and Manufacturing.
• Support due diligence activities requiring assessment of manufacturing routes.
• Provide SME during regulatory inspections and audits.
• Build, lead, and mentor a team; travel 10–20%.

Skills

Regulatory strategy

Cross-functional leadership

Scientific writing

Risk assessment

Project management

Education

PhD in chemistry/chemical engineering (preferred)

Advanced degree in related field

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is seeking a Senior Advisor, Regulatory Starting Material to lead strategy, justification and regulatory positioning for regulatory starting materials across late-stage drug substance programs in the US.

Reporting to CMC leadership, you will collaborate with Process Chemistry, Analytical Development, Regulatory Affairs and CMOs to ensure scientifically sound, regulatorily defensible routes and supply strategies aligned with