Technical Regulatory Writer
That's XPE. For one of our clients we are looking for: Technical Regulatory Writer Organisation description: 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, Module 2 of regulatory files derived from completed eCTD Modules 3, IMPDs as far as CMC information is concerned and 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
If you have a minimum an experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International, an experience with Biologics (if possible preferred over Pharmaceuticals)and an experience in a research laboratory or in regulatory/drug development/public health organization.
You manages own time to meet agreed short-term targets.
You have knowledge of regulatory procedures / systems / guidances and the EU/US variations policy.
You ensures the coherence between contributions / quality of final results.
Of course you have an Scientific university degree, you speak fluently in english and you can use fluently microsoft office.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'.
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