Senior Manager, Global CMC Regulatory Affairs

Role: Senior Manager of CMC Regulatory Affairs, leading global regulatory submissions and strategy for pharmaceutical products. Responsibilities include preparing and reviewing CMC content for INDs, NDAs, and global filings; developing regulatory strategies aligned with development plans; providing expertise to technical and quality teams; engaging with regulatory agencies; proactively identifying and addressing CMC issues; and managing timelines with internal and external teams. Qualifications: B.S. in a scientific discipline (preferably chemistry or pharmaceutical sciences); minimum 5 years of pharmaceutical industry experience with at least 5 years in CMC regulatory affairs; knowledge of drug development, US and global CMC guidelines, and diverse modalities (small molecules, biologics, parenteral, oral). Experience with international markets is preferred. High-Value: expertise across drug development stages, including IND/NDAs/MAAs, with a focus on regulatory strategy, compliance, and cross-functional collaboration. Work setup: hybrid position based in Chicago, requiring at least three days on-site weekly, with periodic travel up to 10%, including potential evening/weekend work.