Skip to Content

Regulatory Affairs & CMC Officer

  • Qualimetrix S.A
  • Αθήνα
  • 24/11/2021

Στοιχεία αγγελίας

Σχέση απασχόλησης - Πλήρης ΑπασχόλησηΕλάχιστη Απαιτούμενη Εκπαίδευση - ΑΕΙΑπαιτούμενη Προϋπηρεσία - Τουλάχιστον 1 έτος/ηΚατηγορίες - Τμήμα Διαχείρισης Ποιότητας, Επιστήμες, Έρευνας & Ανάπτυξης

Περιγραφή

Qualimetrix S.A. is a third party Contract Research Organization, established in 2013, that provides analytical services to pharmaceutical industry.

Qualimetrix S.A. is involved in the development of the Quality part of pharmaceutical products (module 3) as well as in RnD, QC activities and QP services.

In the frame of its activities Qualimetrix S.A. is recruiting ac CMC Officer based in company's laboratory in Athens, Greece.   


Reports to

CMC Senior Officer

Duties

  • Maintains current knowledge of National, European and International Regulatory Legislation and guidelines related to Medicinal Products.
  • Studies Scientific and Legal Documents
  • Assists in Department’s Procedure Preparations
  • Assists in planning the products’ development steps
  • Assists in maintaining compliance with the applicable regulations of the products handled by the Department.
  • Collects and Evaluates Scientific Data
  • Assists in the Product Dossier compilation, collection and  preparation of the needed documentation
  • Communicates with Regulatory Authorities
  • Develops and Prepares Submissions for Product Marketing Authorization, Variations and Renewals
  • Assists in Responses’ Preparation to the Deficiency Letters of Health Authorities and Clients’ questionnaires.
  • Holds responsibility for the maintenance of the department’s physical and electronical archive.


Work experience requirements  

  • At least one-year experience with Dossier preparation for Medicinal Products
  • At least one-year experience with R&D activities in GMP oriented laboratory.


Education requirements

  • University degree in Chemistry, Pharmacy or Biology
  • Good Knowledge of the English Language  ( CEFR B2 )
  • Basic Knowledge of Microsoft Office Applications
  • Knowledge of National and International Regulatory Legislation related to Medicinal Products.


Preferred requirements
  • MSc in Analytical Chemistry or Pharmaceutical Analysis


Company offers

  • Competitive salary
  • Friendly corporate culture
  • Private Insurance
  • High level training
  • Scientific working environment with strong motivating character


Keywords: Chemist, Pharmacist, Biologist, Χημικός, Φαρμακοποιός, Βιολόγος





Περιγραφή Εταιρίας