Global Regulatory CMC Lead – Radiopharma

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.