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Regulatory Affairs Senior Officer
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501-2000
Φαρμακευτικές & Κλάδος Υγείας
ΑθήναΤοποθεσία
Αθήνα
πριν 2 μήνες
Ημ. ανάρτησης
πριν 2 μήνες

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Senior Officer to join our team. This position is based in Athens, Kryoneri.

Responsibilities:

  • Implement the Regulatory strategy and understand relevant documentation requirements
  • Act as responsible Regulatory Team member for assigned regulatory projects
  • Review regulatory documentation for DCP, MRP and National applications in line with assigned timelines
  • Coach, guide and review deliverables of Regulatory Affairs Officers and Associates
  • Liaise with external Regulatory authorities as required.
  • Ensure policies and procedures are properly understood, evaluated and carried out. Make sure that modifications are investigated if necessary.
  • 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
  • Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities


Requirements

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


Benefits

The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.

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Regulatory Affairs Senior Officer
Αθήνα
πριν 2 μήνες
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