About this opportunity
Shionogi Inc. lists this Senior Global CMC Regulatory Lead opportunity in florham park, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Worksite address
florham park, NJ, 07932, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.