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Regulatory Affairs Manager

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Sophie Steels

Sophie Steels

Job description

We are looking for someone with +/- 3 years of regulatory experience with basic regulatory knowledge of EU and US and 

Regulatory experience with projects in clinical development (clinical studies, and documentation related to IND/CTA submissions)

  • Managing of documents, dossiers etc
  • Support of clinical study submissions for early development projects
  • Support team in terms of providing regulatory feedback on specific development topics
  • Support in terms of documentation in systems


  • Experience in Big Pharma and understand that matrix (transversal collaboration, project teams etc)
  • Degree in science (BS/MS)
  • Adapts quickly, flexible and embraces change, looks for solutions on own with some guidance, positive mindset, multitasking, honest/transparent

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