Technical Regulatory Writer

Région
Wavre
Publication
mercredi 8 mars 2017
Date limite
samedi 8 avril 2017
Réf
6FF0AXPE-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:

XPE Pharma & Science is looking for a Technical Regulatory Writer. 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:

The person will be in charge of:

• 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 in writing 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;

Degree: Scientific university degree

Languages: Englis

Offer:
  • Open end contract on XPE payroll;
  • 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