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Ref:RA214
Regulatory Affairs (RA) Officer


PHARMAPLOT logo
1-15
Healthcare
2 days ago
Posted date
2 days ago
Mid-levelMinimum level
Mid-level
Full-timeEmployment type
Full-time

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.

Related tags
regulatory affairs
pharmaceutical / regulatory officer/ pharmaceutical regulations
JOB SUMMARY
Regulatory Affairs (RA) Officer
Gerakas
2 days ago
Mid-level
Full-time

Ref:RA214
Regulatory Affairs (RA) Officer