Regulatory Affairs Officer-Registration

• Competitive benefits package
• Career development
• Continuous training

Your mission

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