For one of our client located in the Walloon Brabant, we are looking for an enthusiastic and experienced Technical Regulatory Writer.
- Do you have a Scientific university degree?
- Do you have a first experience in Regulatory Affairs within the pharmaceutical industry?
- Are you fluent in English (oral and written) and have a good level in French?
The Technical Regulatory Writer is involved in the company’s regulatory activities related to new & existing products, on a domestic or international basis.
- You will be responsible to write CMC parts of regulatory variations
- You will be responsible to write Module 2 of regulatory files derived from completed eCTD Modules 3
- You will be responsible to write IMPDs as far as CMC information is concerned
- You will be responsible to write responses to questions raised by Regulatory Authorities on CMC matters
- You update the internal tracking system linked to their CMC activities
- You're involved in internal initiatives for improvement of processes/ ways of working
- You have a Scientific university degree
- You have experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
- You have a good knowledge of regulatory procedures / systems / guidances
- You have experience working with Biologics (if possible preferred over Pharmaceuticals)
- You have a good knowledge of the EU/US variations policy
- You have experience in a research laboratory or in regulatory/drug development/public health organization
- You can manage own time to meet agreed short-term targets
- You ensure the coherence between contributions / quality of final results
- You are a team player
- You have a good knowledge of Microsoft Word, PowerPoint and Excel
+32 10 68 53 30