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Regulatory Affairs Consultant

  • Location: Denmark
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 26 days ago

  • Sector: Clinical Operations
  • Contact: Megan Hall
  • Duration: 1 year
  • Start Date: ASAP
  • Expiry Date: 30 September 2022
  • Job Ref: JN -082022-473453

The role includes:

  • Evaluation of study feasibility in the country from regulatory perspective
  • Regulatory intelligence (tracking recent changes in CT regulations in the country and informing the client thereof, etc.)
  • Communication with Regulatory Agency, Ethics Committees as needed, on project and non-project level
  • support with clinical trial applications- initial and ongoing; able to compile submission packages under Clinical Trial Directive and Clinical Trial Regulation
  • Review and customization of clinical trial documentation to local requirements incl. Informed Consent Forms and other patient documents

Qualifications

  • Local regulatory insight
  • Experience in the regulatory field of clinical trials of medicinal products (experience with medical devices is a plus)
  • Ability to communicate in Danish in English
  • Availability around 0,5 FTE
  • Preferably located in Denmark

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