Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides
Eli Lilly and Company
August 09, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Key Responsibilities:
- Provide strategic, tactical, and operational regulatory CMC leadership for advanced therapeutic modalities and manufacturing technologies to accelerate synthetic peptides and oligonucleotide development.
- Apply deep technical expertise across CMC development and manufacturing sciences (drug substance, drug product, and analytical sciences), including solid-phase synthesis, purification, conjugation, characterization, and control strategies.
- Support clinical development, global registrations, and lifecycle management using knowledge of global CMC regulatory requirements and guidelines.
- Develop and implement innovative regulatory strategies and platform-based approaches informed by evolving guidance and regulatory precedent.
- Guide CMC development teams on development strategy and lifecycle planning.
- Lead preparation, critical review, and approval of CMC documentation for global submissions and regulatory responses (clinical trial applications, marketing applications, variations/supplements, and health authority queries).
- Lead molecule-specific CMC lifecycle strategy reviews, 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 Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides and/or oligonucleotides (or related complex modalities).
Additional Skills/Preferences:
- Authoring CMC submission content and participating in clinical and marketing authorization applications and regulatory Q&A.
- Experience with peptide/oligonucleotide drug substance and/or drug product development, manufacturing, and commercialization.
- Knowledge of development considerations (synthesis scalability, impurity control, analytical characterization, stability, and delivery systems).
- Experience planning for and participating in Health Authority interactions.
- Strong written/verbal/presentation skills, leadership, risk management, attention to detail, and cross-functional collaboration.
- Provide strategic, tactical, and operational regulatory CMC leadership for advanced therapeutic modalities and manufacturing technologies to accelerate synthetic peptides and oligonucleotide development.
- Apply deep technical expertise across CMC development and manufacturing sciences (drug substance, drug product, and analytical sciences), including solid-phase synthesis, purification, conjugation, characterization, and control strategies.
- Support clinical development, global registrations, and lifecycle management using knowledge of global CMC regulatory requirements and guidelines.
- Develop and implement innovative regulatory strategies and platform-based approaches informed by evolving guidance and regulatory precedent.
- Guide CMC development teams on development strategy and lifecycle planning.
- Lead preparation, critical review, and approval of CMC documentation for global submissions and regulatory responses (clinical trial applications, marketing applications, variations/supplements, and health authority queries).
- Lead molecule-specific CMC lifecycle strategy reviews, 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 Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides and/or oligonucleotides (or related complex modalities).
Additional Skills/Preferences:
- Authoring CMC submission content and participating in clinical and marketing authorization applications and regulatory Q&A.
- Experience with peptide/oligonucleotide drug substance and/or drug product development, manufacturing, and commercialization.
- Knowledge of development considerations (synthesis scalability, impurity control, analytical characterization, stability, and delivery systems).
- Experience planning for and participating in Health Authority interactions.
- Strong written/verbal/presentation skills, leadership, risk management, attention to detail, and cross-functional collaboration.