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Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides @ Eli Lilly

Indianapolis, Indiana, United States of AmericaOnsiteFull-time
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About this role

Join our team as Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (PCM) and lead regulatory strategy for advanced synthetic peptides and oligonucleotides. Drive CMC development, global submissions, and lifecycle management in a dynamic, high-impact environment. Shape the future of life-changing medicines with your expertise in regulatory affairs and CMC leadership.. Category: Research & Development

Skills

cmc regulatory strategy developmentsynthetic peptide drug developmentoligonucleotide drug developmentregulatory submissionsclinical trial application preparationmarket registration supportpost-approval submissionanalytical characterizationsolid-phase synthesisdrug substance developmentdrug product developmentimpurity controlstability characterizationdelivery systems (lipid-based)regulatory compliance

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