Regulatory Affairs & Medical Manager

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

REGULATORY AFFAIRS & MEDICAL MANAGER (M/F)

Mission:

  • 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.

 

Competency:

  • 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.

Contact

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