Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovation - Small Molecules
Eli Lilly and Company
August 24, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio and to support clinical trial applications, market registrations, and post-approval submissions.
Key Responsibilities:
- Deep technical knowledge of small molecule CMC drug development and manufacturing sciences (drug substance, drug product, analytical sciences).
- Knowledge of global CMC regulatory requirements and guidelines for clinical trials and global product registrations/maintenance.
- Develop and implement innovative regulatory strategies and platform approaches based on new guidance and evolving expectations.
- Provide regulatory guidance to support CMC development team decisions on development or lifecycle planning.
- Lead preparation, critical review, and approval of CMC documents for global submissions/responses (clinical trial applications, marketing applications, variations/supplements, and health authority information requests).
- Proactively lead critical review of molecule-specific CMC development and lifecycle strategies.
- Provide high-quality, timely regulatory advice to project teams.
- Make CMC regulatory strategy decisions impacting product submissions across geographies and networks.
Basic Qualifications/Requirements:
- B.S. in a science/engineering/STEM field (advanced degree preferred); e.g., Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology.
- 10+ years Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic molecules.
Additional Skills/Preferences:
- Experience authoring CMC submission content; involvement in clinical trial applications/marketing authorization processes including Q&A.
- Knowledge of major market procedures/regulations; awareness of evolving initiatives.
- Experience with synthetic molecule drug substance and/or drug product development/commercialization/manufacturing.
- Experience planning for and participating in Health Authority meetings; strong risk assessment/management.
- Strong written/spoken/presentation, leadership, negotiation/influence, attention to detail, and teamwork.
Additional Information:
- Location: Indianapolis, IN (remote option may be considered). Relocation assistance provided. Travel: minimal within the US.
- Anticipated wage: $148,500 - $257,400. Full-time employees may be eligible for a company bonus and a comprehensive benefits program (e.g., 401(k), medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being).
Key Responsibilities:
- Deep technical knowledge of small molecule CMC drug development and manufacturing sciences (drug substance, drug product, analytical sciences).
- Knowledge of global CMC regulatory requirements and guidelines for clinical trials and global product registrations/maintenance.
- Develop and implement innovative regulatory strategies and platform approaches based on new guidance and evolving expectations.
- Provide regulatory guidance to support CMC development team decisions on development or lifecycle planning.
- Lead preparation, critical review, and approval of CMC documents for global submissions/responses (clinical trial applications, marketing applications, variations/supplements, and health authority information requests).
- Proactively lead critical review of molecule-specific CMC development and lifecycle strategies.
- Provide high-quality, timely regulatory advice to project teams.
- Make CMC regulatory strategy decisions impacting product submissions across geographies and networks.
Basic Qualifications/Requirements:
- B.S. in a science/engineering/STEM field (advanced degree preferred); e.g., Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology.
- 10+ years Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic molecules.
Additional Skills/Preferences:
- Experience authoring CMC submission content; involvement in clinical trial applications/marketing authorization processes including Q&A.
- Knowledge of major market procedures/regulations; awareness of evolving initiatives.
- Experience with synthetic molecule drug substance and/or drug product development/commercialization/manufacturing.
- Experience planning for and participating in Health Authority meetings; strong risk assessment/management.
- Strong written/spoken/presentation, leadership, negotiation/influence, attention to detail, and teamwork.
Additional Information:
- Location: Indianapolis, IN (remote option may be considered). Relocation assistance provided. Travel: minimal within the US.
- Anticipated wage: $148,500 - $257,400. Full-time employees may be eligible for a company bonus and a comprehensive benefits program (e.g., 401(k), medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being).