Regulatory Affairs Associate

Région
Brussels
Publication
mercredi 12 avril 2017
Date limite
vendredi 12 mai 2017
Réf
6B17EXPE-BE
Contact
Carine Steurs
Fonction
Autre
Niveau d'expérience
2 à 5 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 Associate Organisation description:

Our client, a global research based pharmaceutical company that develops and manufacturers human and animal medicines, is looking for a trilingual (NL-FR-EN) Regulatory Affairs Associate. Your focus is to provide a regulatory service for Belgium and Luxembourg by obtaining and maintaining authorizations for assigned groups of products for human use. Internal and cross-functional interaction with the Marketing, Market Access, Supply Chain, Medical Affairs and Quality Assurance department are daily business.

Job description:

The preparation, submission and follow-up of regulatory dossiers to the Authorities, as well as keeping oversight on these activities by maintaining the local and global regulatory databases are a big part of your role as Regulatory Affairs Associate. In addition, you order CPPs and provide them to the different countries. Handling technical complaints and counterfeits are as well part of your job. Make sure all GMP & GDP related processes are performed in order to assist the responsible person with administrative releases and returns. You are responsible for the coordination of the launch of new and initiating changes to the existing packaging material. First, you coordinate and check the translations (FR/NL/DE) of texts for packaging and SPC and you prepare shortened leaflets. Next, you proofread and review these packaging texts and the labelling information.

Profile:

You have minimum a bachelor degree in Life Sciences and relevant experience in local and European regulatory affairs within the pharmaceutical industry. You are familiar with GDP and the EU regulatory legislation and requirements for medicinal products. English, Dutch and French hold no secrets from you and you can effectively and fluently communicate in all three languages. It's a must that you have a strong sense for organization and a pro-active, customer-oriented and assertive attitude. And finally, if the words: dedicated, team-player, quick-learner and dynamic; cover your personality, you are the (wo)man for this job!

Offer:

You are offered a full time contract (CDI) on XPE's payroll and a competitive salary including an extra-legal package. You can start asap, this project runs initially till the end of 2018, after you get the chance to participate to other projects to broaden and develop your expertise in the life science industry.



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