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Στοιχεία αγγελίας

Σχέση απασχόλησης - Πλήρης ΑπασχόλησηΕλάχιστη Απαιτούμενη Εκπαίδευση - ΜεταπτυχιακόΑπαιτούμενη Προϋπηρεσία - Τουλάχιστον 2 έτος/ηΚατηγορίες - Επιστήμες

Περιγραφή

Pharmaceutical Oriented Services (PharOS) Ltd. is a leading group of companies within the Generics’ Pharmaceutical Industry, established in 2002, dedicated in Product Development, Business Development and Regulatory Affairs across Europe and the globe.

PharOS is currently recruiting for a position within the operations of the CMC team based in Athens, Greece.

Role and Responsibilities
  • Reports to the CMC Manager & CMC Supervisor

Responsible for:
  • Lifecycle management: Maintenance of marketing authorizations:
- by submission of appropriate CMC variations for post-approval changes 
- by submission of renewals
- by monitoring the fulfillment of the commitments made during registration  
  • Create and review product CMC relevant documentation in line with ICH and EMA guidelines intended for Pharmaceutical Dossier post-approval submission of Modules 2-5
  • Compilation and monitoring of the progress of scientific responses to deficiencies raised by the regulatory agencies pertaining to post-approval variations, renewals and commitments.
  • Review and maintain the technical files of the products after their initial approval 
  • Evaluate deviations to batch manufacturing documents, in order to identify any regulatory actions required for the marketed products 
  • Maintain GAP analysis
  • CMC support to clients for Modules 2-5 with regards to the products’ lifecycle 
  • Review, edit and create e-CTD CMC regulatory post-approval submissions 

Experience & Qualification
  • Education to a post-graduate degree level in Pharmacy, Pharmacology, Chemistry, Biology or similar scientific disciplines
  • At least 2 years’ experience in CMC or Regulatory
  • Knowledge of ICH and EMA guidelines related to CMC 
  • Knowledge on the lifecycle management of CMC submissions 
  • Excellent English oral communication and scientific writing skills 
  • Knowledge of pharmaceutical technology related to oral solid dosage forms, oral solutions and injectable presentations

PharOS Ltd Offers
  • Competitive salary
  • Healthcare package
  • Challenging working environment
  • Continuous training on all aspects of CMC while building a vast amount of experience within post-approval stages of the product life-span

Please apply for this position by forwarding your CV in English to: PharOS Ltd, Lesvou str. (end), Thesi Loggos Industrial Zone | GR14452 – Metamorfossi Attikis – Greece, fax +30.210.6664669 or via e-mail.