Senior Global CMC Regulatory Lead

Shionogi Inc. is seeking a Senior Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for assigned assets. The role collaborates with technical, quality, supply and program teams to deliver submission-ready CMC content with a risk-based approach. Responsibilities include leading global CMC strategies, coordinating timelines, liaising with Health Authorities, and authoring regulatory documents across INDs/NDAs/MAAs.