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Senior Regulatory Specialist ( German B1 Knowledge)
ABACUS MEDICINE
📍
budapest, Hungary
Location
budapest
Posted
May 08, 2026
Commute
Local Area
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This job is in your area. Enjoy a short commute and work close to home.
Job Description
*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...
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...