Senior Advisor, Regulatory Starting Materials & CMC Strategy

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

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision and Rx

Flexible benefits

Life insurance

Time off and leave

Well-being benefits

Job summary

Lilly is seeking a Senior Advisor, Regulatory Starting Material in the US. You will lead RSM strategy for drug substance manufacturing across late-stage programs, ensuring regulatory defensibility and alignment with manufacturing readiness.

Reporting to the VP, CMC, you will partner with Process Chemistry, Analytical Development, and Regulatory Affairs to support submissions, health authority interactions, and technology transfer as programs progress toward commercial manufacture.

Qualifications

• Advanced degree in chemistry, chemical engineering, or related field; PhD preferred.
• 7+ years of experience in CMC, process chemistry or drug substance/API development and manufacturing, leading starting material/CMC programs.
• Experience supporting late-stage clinical and/or commercial drug substance programs.
• Deep knowledge of ICH Q11 and regional guidance for starting materials.
• Experience authoring and defending CMC regulatory submissions and health authority interactions.
• Strong background in synthetic/process chemistry and route evaluation.

Responsibilities

• Lead identification, justification, and regulatory strategy for Regulatory Starting Materials per ICH Q11.
• Manage starting material resupply, inventory, forecasting, timing, and contracts.
• Author/review CMC submission content related to RSM for INDs/NDAs/MAAs.
• 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 processes.
• Lead tech transfer and changes affecting RSM as programs scale.
• Manage relationships with CMOs and RSM suppliers; oversee supplier qualification.
• Monitor regulatory guidance and update internal templates and risk assessments.
• Coordinate with Regulatory Affairs, Quality, Supply Chain, Manufacturing for timelines.
• Support due diligence and regulatory inspections related to RSM.
• Build and mentor a team; travel 10-20%.

Skills

ICH Q11 knowledge

CMC regulatory strategy

Regulatory submissions

Health authority interactions

Leadership

Process chemistry

Cross-functional collaboration

Risk assessment

Education

Advanced degree in chemistry or related field

PhD strongly preferred

Job description

Lilly is seeking a Senior Advisor, Regulatory Starting Material in the US. You will lead RSM strategy for drug substance manufacturing across late-stage programs, ensuring regulatory defensibility and alignment with manufacturing readiness.

Reporting to the VP, CMC, you will partner with Process Chemistry, Analytical Development, and Regulatory Affairs to support submissions, health authority interactions, and technology transfer as programs progress toward commercial manufacture.