Technical Regulatory Writer

Région
Wavre
Publication
jeudi 5 octobre 2017
Date limite
dimanche 5 novembre 2017
Réf
7AA02XPE-BE
Contact
Julie Begine
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: Technical Regulatory Writer Organisation description:

XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services. We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product. As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agri-food Industries and the Healthcare & CRO environment. The Technical Regulatory Writer is involved in the company's regulatory activities related to new & existing products, on a domestic or international basis.

Job description:

Writing CMC parts of regulatory variations Writing Module 2 of regulatory files derived from completed eCTD Modules 3 Writing IMPDs as far as CMC information is concerned Writing Responses to Questions raised by Regulatory Authorities on CMC matters Update of internal tracking system linked to their CMC activities Involvement in internal initiatives for improvement of processes/ ways of working

Profile:

Experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International. Knowledge of regulatory procedures / systems / guidances and of the EU/US variations policy. Experience working with Biologics (if possible preferred over Pharmaceuticals) and in a research laboratory or in regulatory/drug development/public health organization. Manages own time to meet agreed short-term targets. Ensures the coherence between contributions / quality of final results. Of course you have a Scientific university degree.

Offer:

What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra-legal advantages! If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client. XPE is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'.



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