Global Regulatory CMC Director - Radiopharma

Posted 2 days ago

orano medPlano (TX)

Regulatory Affairs Managers Biological Product (except Diagnostic) Manufacturing

SENIORITY

Manager

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About the role

Orano Med Theranostics in Plano, TX seeks an Associate Director, Regulatory Affairs - CMC to lead global regulatory CMC strategy for radiopharmaceuticals, oversee preparation of CMC dossiers for US and EU, and ensure timely, high-quality submissions in line with regulatory requirements. You will collaborate with manufacturing, QA, and R&D, manage agency interactions, and drive continuous improvement of internal processes while staying current on CMC guidance.

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