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Regulatory affairs specialist - Belgium, Netherlands  

Company managed [?] Still accepting applications

Posted on : 16 April 2017

Project Description


Responsibilities:
  • Management and update of the pharmaceutical part of the worldwide registration dossiers on the finished products
  • Answers questions from the Health Authorities worldwide
  • Elaboration of variations to make changes to the registration dossiers
  • Responds to queries from the subsidiaries, manufacturing plants and various departments within the company
  • The department is responsible for all CMC (Chemistry-Manufacturing and Control) -aspects of the production of medicines (development – production techniques – analysis of the product- specifications –packaging components -stability until the end phase/expiration date of the medicine) sections of the registration dossiers
  • Registration of products in new markets
  • Preparation of variations
  • Updating registration dossier sections
  • Responds to questions from the Health Authorizations
  • Responds to queries from subsidiaries, manufacturing plants and other departments within the company 




Requirements:
  • You have obtained a (Industrial) Pharmacist degree , Ph.D. or Master degree in a scientific discipline (most of these candidates have a lot of knowledge of medicines) with a first experience in an production environment
  • You have an excellent knowledge of English and Dutch
  • You are very interested in the pharmaceutical industry and the lifecycle of medicines
  • You are able to work autonomously and to set priorities
  • You are accurate, critical and flexible
  • You have a high sense of responsibility
  • You are well organized (respecting strict timings)
  • You have a good eye for detail 



Offers:
  • a young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
  • personal and professional development through guidance, education and knowledge sharing
  • a competence development model focused on your personal ambitions
  • an attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.