Overview
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
Full job description
Our Offer
- 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
Qualifications And Requirements
- 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
Requirements & qualifications
- 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
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