Director, Global Regulatory Affairs – CMC, Lifecycle Innovation

Role: Senior regulatory leader overseeing post-approval CMC lifecycle management for Lilly's parenteral medicines. Responsibilities include developing and executing global regulatory strategies for lifecycle changes, managing submissions (variations, supplements, annual reports, DMFs), and leading site addition and technology transfer activities. The role involves close collaboration with manufacturing, quality, and global regulatory teams to ensure compliant, efficient updates across complex biologic and parenteral product portfolios. Requirements: B.S. in STEM with 7+ years of CMC regulatory or technical experience supporting biologics or complex modalities; advanced degrees (MSc, PharmD, PhD) preferred. High-Value: biologics, parenteral products, post-approval lifecycle management, global regulatory compliance, change control, risk assessment, aseptic manufacturing, and digital lifecycle tools. Stakeholder engagement includes global sites, CMOs, and cross-functional teams. Location: Not specified, but likely hybrid or on-site given global manufacturing coordination.