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Regulatory Affairs Senior CMC Officer
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501-2000
Φαρμακευτικές & Κλάδος Υγείας
ΑθήναΤοποθεσία
Αθήνα
πριν 2 μήνες
Ημ. ανάρτησης
πριν 2 μήνες
Entry / ΑρχάριοςΕπίπεδο εμπειρίας
Entry / Αρχάριος

DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is currently looking for a talented Regulatory Affairs CMC Officer to join our team in Athens (Kryoneri). This position reports directly to the Regulatory Affairs CMC Manager.

Main duties and responsibilities:

  • Understanding of Regulatory strategy and documentation requirements
  • Act as responsible Regulatory Team member for assigned regulatory projects
  • Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
  • Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products
  • Liaise with external Regulatory authorities as required
  • Preparation of submissions including CMC variation filling


Requirements

  • BSc Degree in Chemistry, Biology or relevant field.
  • 4-6 years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization
  • Knowledge of CMC and global regulatory guidelines
  • Fluency in English and good use of MS Office skills
  • Strong organization skills, multi-tasking and able to meet deadlines
  • Effective communication and relationship management
  • Ability to work under pressure, resilience


Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

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Regulatory Affairs Senior CMC Officer
Αθήνα
πριν 2 μήνες
Entry / Αρχάριος
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