Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides
Eli Lilly and Company
August 30, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Key Responsibilities
- Provide strategic, tactical, and operational regulatory CMC leadership to accelerate development of a synthetic peptides and oligonucleotide portfolio for clinical trial applications, market registrations, and post-approval submissions.
- Apply deep technical knowledge of synthetic peptide/oligonucleotide CMC development and manufacturing sciences (drug substance, drug product, and analytical sciences such as solid-phase synthesis, purification, conjugation, characterization, and control strategies).
- Use global CMC regulatory requirements and guidelines to support clinical development, product registrations, and lifecycle management.
- Develop and implement innovative regulatory strategies and platform-based approaches using evolving guidance and regulatory precedent.
- Provide regulatory guidance and make well-informed decisions that align global CMC submission strategies across geographies, teams, and platform approaches.
- Lead preparation, critical review, and approval of CMC documentation for global submissions and responses (clinical trial applications, marketing applications, variations/supplements, and health authority query responses).
- Lead critical reviews of molecule-specific CMC development and lifecycle strategies, including impurity profiles, sequence-related variants, delivery systems, and stability.
Basic Qualifications/Requirements
- B.S. in a science/engineering/STEM field (advanced degree preferred).
- 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides/oligonucleotides (or related advanced modalities).
Additional Skills/Preferences
- Experience authoring CMC submission content for peptides/oligonucleotides, including clinical trial and marketing authorizations and regulatory Q&A.
- Knowledge of major global regulatory procedures and evolving expectations for complex modalities/platform technologies.
- Experience with peptide/oligonucleotide drug substance/drug product development, manufacturing, and commercialization.
- Understanding of synthesis scalability, impurity control, analytical characterization, stability, and delivery systems.
- Experience managing complex submission strategies; planning for and participating in Health Authority interactions.
- Strong risk assessment, communication, leadership/influencing, attention to detail, and cross-functional collaboration.
Benefits
- Anticipated wage: $148,500 - $257,400.
- Eligibility for a company bonus (depending on company and individual performance).
- Comprehensive benefits (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits).
- Provide strategic, tactical, and operational regulatory CMC leadership to accelerate development of a synthetic peptides and oligonucleotide portfolio for clinical trial applications, market registrations, and post-approval submissions.
- Apply deep technical knowledge of synthetic peptide/oligonucleotide CMC development and manufacturing sciences (drug substance, drug product, and analytical sciences such as solid-phase synthesis, purification, conjugation, characterization, and control strategies).
- Use global CMC regulatory requirements and guidelines to support clinical development, product registrations, and lifecycle management.
- Develop and implement innovative regulatory strategies and platform-based approaches using evolving guidance and regulatory precedent.
- Provide regulatory guidance and make well-informed decisions that align global CMC submission strategies across geographies, teams, and platform approaches.
- Lead preparation, critical review, and approval of CMC documentation for global submissions and responses (clinical trial applications, marketing applications, variations/supplements, and health authority query responses).
- Lead critical reviews of molecule-specific CMC development and lifecycle strategies, including impurity profiles, sequence-related variants, delivery systems, and stability.
Basic Qualifications/Requirements
- B.S. in a science/engineering/STEM field (advanced degree preferred).
- 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides/oligonucleotides (or related advanced modalities).
Additional Skills/Preferences
- Experience authoring CMC submission content for peptides/oligonucleotides, including clinical trial and marketing authorizations and regulatory Q&A.
- Knowledge of major global regulatory procedures and evolving expectations for complex modalities/platform technologies.
- Experience with peptide/oligonucleotide drug substance/drug product development, manufacturing, and commercialization.
- Understanding of synthesis scalability, impurity control, analytical characterization, stability, and delivery systems.
- Experience managing complex submission strategies; planning for and participating in Health Authority interactions.
- Strong risk assessment, communication, leadership/influencing, attention to detail, and cross-functional collaboration.
Benefits
- Anticipated wage: $148,500 - $257,400.
- Eligibility for a company bonus (depending on company and individual performance).
- Comprehensive benefits (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits).