Regulatory Affairs Officer-Registration
Posted Updated
- Competitive benefits package
- Career development
- Continuous training
Adragos 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
- 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