To meet the upcoming demand of our clients in the Pharmaceutical Sector, we are looking for Technical Regulatory Writers.
- Do you hold a Scientific university degree?
- Do you have experience in writing CMC parts of regulatory documents?
- Are you fluent in English?
Then you might be the candidate we are looking for. Don’t hesitate and apply now!
As Technical Regulatory Writer you are involved in the company’s regulatory activities related to new & existing products, on a domestic or international basis.
- You write CMC parts of regulatory variations
- You writ Module 2 of regulatory files derived from completed eCTD Modules 3
- You write IMPDs as far as CMC information is concerned
- You write Responses to Questions raised by Regulatory Authorities on CMC matters
- You update internal tracking system linked to their CMC activities
- You are involved in internal initiatives for improvement of processes/ ways of working
- You hold 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 knowledge of regulatory procedures / systems / guidances
- You have experience working with Biologics (if possible preferred over Pharmaceuticals)
- You have 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 team player
- You have skills in Microsoft Word, PowerPoint and in Excel
- You are fluent in English
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