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Regulatory Affairs Senior Officer/ EU, ELPEN

ELPEN Pharmaceutical Co. Inc., a Greek Pharmaceutical Company, is seeking a Regulatory Affairs Senior Officer/ EU.

Responsibilities:

The role will be responsible for handling and supporting internal Regulatory Affairs processes in EU countries excluding Greece, as part of Regulatory Affairs team. Regulatory Affairs Senior Officer/ EU reports directly to Regulatory Affairs Manager/ EU and Regulatory Affairs Director and has close collaboration with third party Organizations, EU Health Authorities as well as Company’s liaising departments.

 More specifically, the role:

  • Communication with Partner companies/third parties
  • Communication with EU Regulatory Authorities
  • Preparation and timely submission of MAAs, variations, renewals
  • Monitoring & administrative implementation of EU Registration legislation
  • Monitoring & timely implementation of any decisions/recommendations derived from

Health Authorities and Partners

  • Maintenance of Products database
  • Preparation and submission of e-CTD files
  • Filing & archiving RA-related documents
  • Operating Internal Data Management System

 

Education (minimum/desirable)
Minimum requirements

  • University Degree in Health Sciences, preferably in Pharmacy
  • Minimum 3 years of experience in Pharmaceutical Regulatory Affairs, including active participation in teams supporting registration in EU countries excluding Greece
  • Very good Knowledge of CTD structure and e-CTD programme
  • Excellent interpersonal skills and ability to work as part of a cross functional team
  • Excellent use of Microsoft Office

Languages

  • Excellent command of English (oral & written)

If you want to apply for this position please send your CV to the email Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε. with the indication “RA03”.

 

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