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Shionogi Inc.

Regulatory Affairs Leader, US & Global Strategy

florham park, NJ

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Job description

Shionogi Inc. seeks a Director, Regulatory Affairs to lead global regulatory strategies for development programs and U.S. lifecycle planning for marketed products.

You will partner with cross-functional teams to shape submissions, manage agency interactions, and ensure timely regulatory delivery. The ideal candidate has 10+ years of regulatory experience in pharma/biopharma, a life-sciences degree (advanced degree preferred), and a proven record leading major submissions (INDs, NDAs, BLAs) and

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Worksite address

florham park, NJ, 07932, US

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