Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls; CMC), Platform Inn

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

This role provides strategic, tactical, and operational regulatory CMC leadership across advanced therapeutic modalities and manufacturing technologies to accelerate development of the synthetic peptides and oligonucleotide portfolio, supporting clinical trial applications, market registrations, and post‑approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent, coupled with deep technical expertise in CMC development and manufacturing processes specific to synthetic peptides and oligonucleotides.

• Deep technical knowledge of synthetic peptide and oligonucleotide CMC drug development and manufacturing sciences across modalities and platforms, including drug substance, drug product, and analytical sciences (e.g., solid‑phase synthesis, purification, conjugation, characterization, and control strategies).
• Knowledge of global CMC regulatory requirements and guidelines for synthetic peptides and oligonucleotides to support clinical development, global product registrations, and lifecycle management of approved products.
• Development and implementation of innovative regulatory strategies and platform‑based approaches, incorporating evolving external expectations (e.g., emerging guidance, novel modality considerations, and regulatory precedent).
• Provide regulatory guidance enabling CMC development teams to make well‑informed decisions on development strategies and lifecycle planning.
• Lead preparation, critical review, and approval of CMC documentation for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and responses to health authority queries.
• Take a proactive leadership role in the critical review of molecule‑specific CMC development and lifecycle strategies, including considerations unique to peptides and oligonucleotides (e.g., impurity profiles, sequence‑related variants, delivery systems, and stability).
• Provide high‑quality, timely, and clear regulatory advice to support project teams in advancing complex modalities.
• Make decisions on CMC regulatory strategies impacting global submissions, ensuring alignment across geographies, teams, and platform approaches.

• B.S. degree in a science, engineering, or related STEM field (advanced degree preferred), such as Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biochemistry, Molecular Biology, or similar.
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides, oligonucleotides, or related complex modalities. Candidates with broader experience in advanced modalities are encouraged to apply.

• Experience authoring CMC submission content for peptides and/or oligonucleotides, including participation in clinical trial and marketing authorization applications and responses to regulatory questions.
• Knowledge of major global regulatory procedures, regulations, and evolving expectations for complex modalities, including platform technologies.
• Relevant experience in peptide and/or oligonucleotide drug substance and/or drug product development, manufacturing, and commercialization.
• Demonstrated understanding of key development considerations for peptides and oligonucleotides (e.g., synthesis scalability, impurity control, analytical characterization, stability, and delivery systems such as…