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Senior Regulatory Specialist ( German B1 Knowledge)

Company

Abacus Medicine Group

Location

budapest, budapest

Type

Full-time

*Your knowledge can open doors for patients worldwide — become a key driver of regulatory excellence with us.** *Come and join us as a Senior Regulatory Specialist.** *The Team** You’ll be joining an 8‑member Regulatory Marketing Authorization team that supports the German and Austrian markets within a wider organization of 130 colleagues. Our group plays a key role in both national (member‑state) marketing authorization processes and broader European regulatory activities. *We Would Like To** According to the requirements of the assigned end market, you will be responsible for: Acting as a specialist within the team Acquiring marketing authorizations for medicines in line with SOPs, WIs, and relevant regulatory guidelines Maintaining existing marketing authorizations according to market‑specific requirements and internal procedures Preparing and sending notifications to Trademark Holders in compliance with SOPs and WIs Managing end‑to‑end submission processes for the German an...

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