Regulatory Affairs Specialist

Région
Brussel
Publication
mercredi 12 avril 2017
Date limite
vendredi 12 mai 2017
Réf
6B03AXPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Regulatory Affairs Specialist Organisation description:

XPE Pharma & Science is currently looking for a temporary Regulatory Affairs Specialist, for one of its clients, a well-known company in the pharmaceutical area. The candidate can be a school graduate, but has to be motivated and willing to learn. An (Industrial) Pharmacist degree , Ph.D. or Master degree in a scientific discipline with a first experience in an production environment is the desired profile; English and Dutch are a must for this mission.

Job description:
  • 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
Profile:
  • Has 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 (desired profile);
  • Has an excellent knowledge of English and Dutch;
  • Is very interested in the Pharmaceutical Industry;
  • Is able to work autonomously and to set priorities;
  • Is accurate, critical and flexible;
  • Has a high sense of responsibility;
  • Is well organized (respecting strict timings);
  • Has a good eye for detail.

Additional info:

  • The candidate can be a school graduate, but has to be motivated and willing to learn (right attitude!);
  • Candidates with a few years of experience as a pharmacist, but who are looking for another kind of function within pharma, can be interesting too;
  • Experience is not mandatory! Training on the job;
  • A strong interest: lifecycle of medicines & the pharmaceutical industry.
Offer:
  • Open end contract on XPE payroll;
  • Highly professional working environment & opportunity to have a good start into your career


Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713