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International Regulatory Affairs Specialist - Spain  

MABxience (company)


Posted on : 13 April 2017

Project Description

Global Responsibility: 
  • Will be Responsible for the implementation of regulatory strategies through coordination and preparation of submission documents for the registration of the Biotech products in international markets.
  • Ensure timely registration of products in compliance with applicable regulation and guidelines. 

Main Requirements: 
  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline. 
  • 5/6 years Regulatory experience and previous experience in registration of Biological products. 
  • Thorough knowledge of registration procedures in EU (mainly centralized procedure) and desirable experience also in Latin America and Asia. 
  • Knowledge of CMC, MAA is desirable. 
  • Willing to travel, at least 25%. 
  • Permanent contract. 
  • Full time.