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Regulatory Affairs Manager - CORONIS

Operating for almost two decades in Greece and Cyprus, CORONIS has been delivering a full spectrum of services to national and international pharmaceutical, biotechnology and medical device industries and other healthcare-related organisations. As a Contract Research Organization (CRO), CORONIS wishes to contribute in the delivery of life-changing therapies to patients worldwide.

Currently we are looking for a Regulatory Affairs Manager to join our team!

The Regulatory Affairs Manager is responsible for the development and implementation of a successful regulatory strategy for our clients’ products (prescription medicines, essential similar products, OTCs, Cosmetics and Food Supplements).

Primary responsibilities:

  • Keeping up to date with local and EU legislation, guidelines and practices
  • Preparing and submitting New Drug Applications (CTD) through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures (MAA)
  • Maintenance of Marketing Authorization Applications (Variations and Renewals) abiding to post approval commitments, as well as handling of withdrawals and transfers of Marketing Authorizations
  • Reviewing of artworks and promotional material to ensure regulatory compliance
  • Adaptation and translation of Product Information (SmPC, labelling & PIL) in compliance with the EU and local legislation.
  • Supporting pricing and reimbursement activities
  • Registration of medical devices to the National/European database and preparation/maintenance of technical dossier for CE mark
  • Providing regulatory intelligence to our clients by reviewing and evaluating marketing information, regulations, guidelines, procedures etc.
  • Liaising closely with the Health Authorities and ensuring the optimum relationship between the regulatory authorities and our customers

Qualifications

  • University degree in life sciences, pharmacology or chemistry
  • At least 3 years of previous demonstrated experience in the regulatory field
  • Excellent command (written and verbal) of English language and proficient knowledge of medical terminology
  • IT literacy (MS Windows, MS Office, Internet Use)
  • Solid understanding of the drug development process, pharmaceutical legislation and scientific matters
  • Ability to interact professionally with customers and work effectively within a team
  • Strong strategic thinking, analytical and problem-solving skills
  • Excellent organizational, prioritizing and communication skills
  • Ability to manage multiple and varied tasks with attention to detail
  • Effective time management to ensure project deadlines are met
  • Ability to work independently with regular oversight and open to seeking guidance when necessary

If you fulfill the requirements of this position and you’re interested in joining our team, please send your CV to: Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.

 

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