Unknown Company

Senior Global CMC Regulatory Lead

florham park, nj • Posted 2 weeks ago
Onsite Full Time Management & Operations

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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Senior Global CMC Regulatory Lead in florham park at Unknown Company

This position is listed as full time and onsite.

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