Technical Regulatory Writer

Région
Wavre
Publication
jeudi 6 juillet 2017
Date limite
dimanche 6 août 2017
Réf
6F1E6XPE-BE
Contact
Andreea Ardelean
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: Technical Regulatory Writer Organisation description:

For one of its clients, XPE Pharma & Science in looking for a Technical Regulatory Writer. This is a replacement of someone in maternity leave, thus the duration of the mission is limited to 3 months (end of September). There might be possibility of extension of the contract, but is not 100 5 sure.

Job description:

The Technical Regulatory Writer is involved in the company's regulatory activities related to new & exisiting products, on a domestic or international basis.

  • 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:

Hard Skills:  Experience inwriting CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International  Knowledge of regulatory procedures / systems / guidances  Experience working with Biologics (if possible preferred over Pharmaceuticals)  Knowledge of the EU/US variations policy  Experience in a research laboratory or in regulatory/drug development/public health organization Soft skills :  Manages own time to meet agreed short-term targets  Ensures the coherence between contributions / quality of final results  Team player Education, Methodology & Certification Requirements  Scientific university degree Language Proficiency Requirements English Fluent

Offer:

Perm contract with XPE Pharma & Science Highly professional working environment.



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