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Senior Director Global CMC Regulatory Strategy

Talnt, Gaithersburg, MD, United States


An innovative biopharmaceutical company is seeking a CMC Director or Senior Director of Regulatory Affairs responsible for overseeing global Chemistry, Manufacturing, and Controls regulatory strategy and execution. This strategic role includes leading CMC submissions for INDs, NDAs, and ensuring compliance with FDA and EMA regulations. The ideal candidate will have extensive experience in regulatory affairs within the biotech sector and strong project management skills, involving cross-functional collaboration to drive regulatory deliverables.
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