PharmaPlot is a company focused on the development, out- licensing and supply of high-quality generic pharmaceutical products and value-added medicines. Currently, the company is recruiting a Regulatory Affairs (RA) Officer based in company's site in Athens, Greece.
Main responsibilities
- Prepare, compile, and submit regulatory documentation to health authorities.
- Ensure compliance with EMA guidelines, GMP, GLP, and GCP.
- Assist in Product Dossier compilation, collection and preparation of the needed documentation.
- Prepare Submissions for Product Marketing Authorizations and Renewals.
- Monitor regulatory changes and evaluate their impact.
- Maintain department’s physical and electronical archive and tracking systems.
Work experience
At least 2 years of experience in Regulatory Affairs (pharmaceuticals ).
Education requirements
-Bachelor’s degree in Pharmacy, Chemistry, Biology, or related scientific field.
-Good Knowledge of the English Language (CEFR B2) and technical writing skills.
-Knowledge of National and International Regulatory Legislation related to Medicinal Products.
Preferred requirements
-MSc in Analytical Chemistry or Pharmaceutical Analysis.
Company offers
-Competitive salary
-Friendly corporate culture
-Private health insurance
-High level training
-Motivating scientific working environment
We assure you that all applications will be treated in strict confidence.
Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.