CMC Pharmaceutical Specialist

4 days ago

Acharnes, Attica, Greece beBeeRegulatory Full time
Job Description

KLEVA Pharmaceuticals S.A. is a privately owned pharmaceutical and fully integrated company with over 50 years of operation in Greece.

The company develops and manufactures generic products, focusing on Pharmaceuticals (Rx & OTC).

Two manufacturing facilities in the North of Athens, Greece, are equipped with high technology machinery and have the manufacturing potential for a wide range of pharmaceutical forms.

The mission is to offer a flexible, fully scalable, qualitative, and cost-effective product development in a wide range of dosage forms. The company registers and exports its products to a number of regulated and non-regulated markets around the world.

Key Responsibilities
  • Coordination on the compilation of the CTD dossiers
  • Supervision of the implementation of the EU regulations and ICH guidelines in the compilation of the CTD dossiers
  • Overseeing CMC-wise projects that are under development
  • Design of regulatory strategy for dossier submission
  • Coordination of the responses to questions raised during the assessment of the product dossier by the Authorities
  • Coordination and collaboration with clients on the collection of documentation required for dossier submission
  • Review of CTDs of pharmaceutical products
  • Keep updated on regulations and guidelines published by competent authorities
Requirements
  • Bachelor's degree in sciences (preferably Pharmacy or Chemistry)
  • Fluency in English both written and oral
  • Excellent computer literacy (MS Office)
  • Previous professional experience of at least 5 years in a pharmaceutical company in the field of dossier compilation
  • Be multitasking
  • Cope with deadlines
  • Excellent work in a team
Benefits
  • Work in a friendly and challenging environment
  • Competitive salary
  • Private insurance
  • Personal development opportunities

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