Regulatory Affairs & Medical Manager

Square Marie Curie 20, 1070 Anderlecht
vendredi 31 mars 2017
Date limite
lundi 15 mai 2017
RM 2017 03
Type de contrat
Temps de travail
Temps plein



  • The Regulatory Affairs & Medical Manager will contribute to the development and the implementation of the strategy for the Benelux Organization being responsible for all planning, budgetting and financial control of Regulatory Affairs & Medical programs;
  • He/ She manages and leads the local registration process by ensuring approvals of new products, distribution permits, import permits and amendments (variations, five-year renewal, post approval commitments) to products within Benelux;
  • He/ She develops the pricing and reimbursement strategy of the Benelux affiliate, including the contacts with the local authorities;
  • Working as Qualified person for all vigilance area’s ( pharmaco-vigilance, materio-vigilance, …) ensuring the timely submission of all pharmacovigilance and materiovigilance follow-up reports;
  •  Responsible of medical questions from patients, doctors, pharmacists or others;
  • Qualified person in charge of information and medical advertising including reviewing the iconography of the packaging from a regulatory perspective; 
  • Responsible for the conception of a quality system in accordance with Distribution good practices;
  • Represent the company within the committees of professional associations.



  • You hold a master degree in Pharmaceutical sciences and you have a first successful professional experience in the pharmaceutical sector, by preference in a regulatory affairs role; 
  • You are a self-starter with strong influencing skills and you can translate strategic guidelines into concrete action points;
  • You are committed to achieve your objectives and you integrate new information easily;
  • You can organize your work independently while according the right priorities to your different job responsibilities;
  • You are able to transfer your technical knowledge in an understandable way to colleagues from other departments;
  • You are an excellent communicator in Dutch, French, and English.


  • Interested ? Please send your resume to Kathleen Duyshaver – Square Marie Curie 20, 1070 Anderlecht or by mail (Reference: RM/ 201703)

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