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ELPEN Pharmaceutical Co. Inc. – Regulatory Affairs Officer/Senior Officer, GR_CY

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

 Job Description

As a Regulatory Affairs Officer/Senior Officer you will be responsible for handling and supporting Regulatory Affairs processes in Greece and Cyprus, as part of the Regulatory Affairs team. You will report directly to the Regulatory Affairs Manager and Regulatory Affairs Director and align and collaborate with third party Organizations, National Regulatory Authorities as well as various departments within the Company.

Main Duties and Responsibilities:

  • Liaise with National Regulatory Authorities
  • Liaise with various departments within the Company in order to collect all information and documentation necessary for the preparation of regulatory submissions
  • Liaise with Partner companies/third parties
  • Prepare and submit MAAs, variations, renewals in a timely manner and as per the agreed Regulatory Strategy
  • Monitor & implement the EU and national Pharmaceutical legislation in Greece and Cyprus with regard to product registration
  • Ensure regulatory compliance of registered products
  • Prepare and submit e-CTD files
  • Maintain Internal Data Management Systems

Minimum requirements

  • Bachelor Degree in Pharmacy, Biology, Chemistry or other related field
  • Minimum 2 years of experience in similar position in the pharmaceutical industry
  • Knowledge of EU Pharmaceutical legislation with regards to products registration
  • Strong verbal and written communication skills. Able to communicate in an effective manner with other departments and work as part of a cross functional team
  • Fluent in English, both in verbal and written communication
  • Very good knowledge of CTD structure and e-CTD programme
  • Strong organization and computer skills

If you want to apply for this position please send your CV to the email hr-ra@elpen.gr with the indication “RA05”.

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