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Regulatory Affairs Associate (CMC Lifecycle) at SAP

Setup
Hybrid
Location
Bulgaria
Type
Full-time
Level
mid
Posted

Summary from listing

Teva is hiring a CMC Regulatory Affairs Specialist to manage post-approval CMC changes across EU and international markets. The role involves creating and assessing registration dossiers, preparing variation packages, evaluating technical documentation, responding to regulatory queries, supporting renewals, and improving regulatory processes. It is a hybrid position based at either the Opava site in the Czech Republic or the Sofia site in Bulgaria, and requires an MSc in Pharmacy, Chemistry, or Biology, at least two years of CMC Regulatory Affairs experience, strong English, and good IT skills.

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