Regulatory Affairs Officer-Registration
Adragos Pharma
Athens, Greece
🛂 Not mentioned
Facility Athens
Full Time
Posted 1 month ago
Job description
Our offer
- Competitive benefits package
- Career development
- Continuous training
Your mission
Your missionAdragos Pharma Athens, a member of Adragos Pharma, is a Contract Development Manufacturing Organization based in Europe. Our primary focus is to provide high-quality research for the development of generic and generic-plus products. To support our continued growth, we are looking for a Regulatory Affairs Officer-Registration to join our team in Athens and contribute to the regulatory activities supporting the registration and lifecycle management of our pharmaceutical products.
Responsibilities:
- Compilation of Module 1 of registration dossiers (PIL, SmPC, ERA, RMP) in accordance with EU directives / UK regulations
- Preparation of dossier sequence (initial MAA, variation, renewal) in eCTD and submission via relevant authority portals.
- Management of authority queries and preparation of deficiency responses concerning M1
- eCTD sequence management and lifecycle maintenance
Your profile
- B.Sc in Pharmacy. M.Sc. will be considered an asset
- Excellent command of English & Greek – both oral and written
- Prior Regulatory Affairs experience in module 1 preparation (3-4 years)
- Excellent MS Office/eCTD manager skills
Disclaimer: this job information comes directly from Adragos Pharma's job board (Personio). We show it as published and do not modify it. Always confirm the details on the original posting before applying.
Quick info
Athens · Greece
Full Time
Posted 1 month ago
Still open · checked 15 Nov 2026
Source
Adragos Pharma's career page (Personio)
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