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Trades Workforce Solutions

Senior CMC Regulatory Lead, Drug Product — Hybrid

Trades Workforce Solutions, WorkFromHome

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A leading regulatory affairs consulting firm is looking for a Senior Manager, Regulatory Affairs CMC with a focus on Drug Product strategy. The role entails drafting regulatory dossiers, ensuring compliance with EU and FDA expectations, and mentoring a direct report. Ideal candidates will have strong technical CMC backgrounds, experience with Fill/Finish processes, and regulatory writing skills. This position involves overseeing formulation and stability activities alongside cross-functional teams, offering a hybrid working model.
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