Technical Regulatory Writer

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?
Job Description 

The Technical Regulatory Writer is involved in the company’s regulatory activities related to new & existing products, on a domestic or international basis.

Responsibilities 
  • 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
Profile 
  • 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
Contact Information 

Amandine Planche
+32 10 68 53 30
amandine.planche@valesta.com

Application form : Technical Regulatory Writer

Files must be less than 3 MB.
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Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
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