Technical Regulatory Writer
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.
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 FluentOffer:
Perm contract with XPE Pharma & Science Highly professional working environment.
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