- Competitive benefits package
- Career development
- Continuous training
Regulatory Affairs Officer-Registration
Athens, Attiki, Greece
Full-time
Permanent employee
Our offer
Your mission
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.
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
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
About us
Adragos Pharma is a reliable Contract Development and Manufacturing Organization (CDMO) headquartered in Munich, Germany. We provide comprehensive development and manufacturing services for drug products, including sterile and non-sterile liquids, solids, and semi-solids. Our expertise also covers biologicals, orphan drugs, clinical trials, fill-and-finish, and lyophilization, offering end-to-end solutions from product development to commercial supply.
With production sites in Germany, France, Greece, Norway, Japan, and Switzerland, we ensure high-quality manufacturing across all stages of the drug development process.
Founded in 2020, Adragos Pharma has rapidly grown through an ambitious buy & build strategy, supported by FSN Capital. With a team of over 900 professionals, we are expanding our operations across Europe, North America, and Japan to become a global leader in the CDMO sector.
As a key player in the pharmaceutical industry, CDMOs like Adragos produce 25% of all drugs globally, ensuring access to essential medications. With increasing healthcare demands, we continue to innovate and set new standards in drug manufacturing.
You want to be part of our dynamic growth? Then apply now!
With production sites in Germany, France, Greece, Norway, Japan, and Switzerland, we ensure high-quality manufacturing across all stages of the drug development process.
Founded in 2020, Adragos Pharma has rapidly grown through an ambitious buy & build strategy, supported by FSN Capital. With a team of over 900 professionals, we are expanding our operations across Europe, North America, and Japan to become a global leader in the CDMO sector.
As a key player in the pharmaceutical industry, CDMOs like Adragos produce 25% of all drugs globally, ensuring access to essential medications. With increasing healthcare demands, we continue to innovate and set new standards in drug manufacturing.
You want to be part of our dynamic growth? Then apply now!