Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovation - Small Molecules

Role: Lead regulatory CMC expert for Lilly’s small molecule portfolio, focusing on development, registration, and lifecycle management. Responsibilities: provide strategic and technical regulatory guidance across modalities and platforms, lead preparation and review of CMC documents for global submissions, ensure compliance with international regulations, and develop innovative regulatory strategies adapting to evolving guidelines. Qualifications: B.S. in science or engineering; 10+ years in Regulatory CMC supporting clinical and commercial phases of synthetic molecules. Preferred: experience authoring submission content, managing complex regulatory strategies, and involvement in health authority interactions. HighValue: expertise in small molecule CMC development, global regulatory landscape, synthetic drug substance and drug product processes, clinical trial applications, and market registration; ability to influence cross-functional teams. WorkSetup: Indianapolis-based, with possible remote options; minimal US travel.