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Global Regulatory CMC Lead – Radiopharma
Job in
Plano, Collin County, Texas, 75086, USA
Listed on 2026-08-22
Listing for:
Orano USA
Full Time
position Listed on 2026-08-22
Job specializations:
-
Healthcare
Healthcare Compliance -
Pharmaceutical
Healthcare Compliance
Job Description & How to Apply Below
Orano USA seeks an Associate Director, Regulatory Affairs – CMC to lead global regulatory CMC strategy for radiopharmaceuticals. You will prepare and manage CMC documentation and submissions for the US and EU, collaborating with CMC, Manufacturing, Quality, and R&D teams to ensure compliance and timely approvals.
The role requires a minimum of 8 years in Regulatory CMC, strong written and verbal communication, and experience with IND/CTA, DMF/ASMF, and eCTD processes.
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