shionogiFlorham Park, NJ
Senior Global CMC Regulatory Lead
Senior Global CMC Regulatory Lead
Senior Global CMC Regulatory Lead
shionogiFlorham Park, NJ
today
Biological Product ManufacturingPharmaceutical Preparation ManufacturingResearch and Development in Biotechnology
Apply for this role (opens in a new tab)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.
Also on the board Same function, level within a rung
Level
Manager
Location
Florham Park, NJ
Occupation
Regulatory Affairs Managers
Industry
Biological Product Manufacturing
Posted
today