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Clinical Regulatory Officer

- Leuven

Job content
  • Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications
  • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
  • Review translations of essential documents subject to clinical trial submission
  • Track the regulatory project documentation flow
  • Review documents to greenlight IP release to sites
  • Manage safety reporting to authorities
  • Deliver regulatory training to project teams
  • Assist with feasibility research and business development requests
  • Bachelor or Master degree in life sciences, or an equivalent combination of education, training and experience
  • Prior experience with clinical trial submissions in Belgium
  • Full working proficiency in Dutch, English and French
  • Proficiency in MS Office applications
  • Detail-oriented
  • Ability to learn, plan and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills

More information? Contact: or +32 16 30 95 09