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Regulatory Affairs Specialist - Italy  

Company managed [?] Still accepting applications

Posted on : 05 July 2017

Project Description

Main activities: 
  •   Preparation of the documentation required for submission of the Clinical Trial Application and authorization procedures for placing on the national and centralized marketing; 
  •   Checking printed medicines in order to Ensure the integrity and quality of labeling and of product information; 
  •   Prepare the technical documentation on the occasion of changes AIC; 
  •   Work with the Market Access for the regulatory aspects of the activities related to the launch of products on the market; 
  •   Prepare / update the documentation in order to Ensure regulatory compliance; 
  •   Rating change and their regulatory impact; 
  •   Managing the documents. 


requirements: 
  •   Experience of at least two years in the regulatory field, Gained in companies with production manufacturing sterile finished products; 
  •   Knowledge of English Both written and spoken.