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Menarini Hellas - Regulatory Affairs Officer

Menarini Hellas, an international pharmaceutical company seeks to recruit a dynamic professional for the Regulatory Affairs Dpt.

The candidate will ensure the appropriate licensing of the company products and their maintenance to the Greek & Cypriot Regulatory Authorities.

The Main Responsibilities Include

  • Access and reviews all scientific and technical evidences and responsible for the effective communication with the local Health Authorities for the Marketing Authorizations and registration notification of all products.
  • Performs all necessary activities for the preparation and submission of applications for approval of variations/new Marketing Authorizations/Renewals to Greek and Cypriot authorities through national, mutual, decentralized and centralized procedures.
  • Responsible for translation of regulatory documents (product information, variations applications, variation approvals, marketing authorizations) of all products of the company
  • Responsible for the notification to health authorities (Cypriot & Greek) of non-pharmaceutical products.
  • Maintains up-dated file in the company with the essential legal documents as well as the archives of the official correspondence regarding the department.
  • Supports PV and Quality function.
  • keeping up to date with changes in regulatory legislation and guidelines

Skills and Qualifications

  • University Degree in Pharmacy, Medicine, Biology, Chemistry.
  • Fluency in English / Fully computer literate.
  • Minimum 2 years of experience in Pharma sector.
  • Knowledge of regulations, legislation, policies and procedures related regulatory affairs procedures.
  • Time management skills & Ability to work under pressure and to strict deadlines.
  • Team player.

Remuneration
The company offers a competitive remuneration package and career prospects.

If you meet the above qualifications and believe that you can respond dynamically to the requirements of the position, please send us a curriculum vitae by entering the code position RA_2020 at Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.

All applications will be treated as confidential.

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