Regulatory Affairs and Safety Submission Specialist

6 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
Job Description

We are seeking an experienced Clinical Trial Operations Manager to join our team at Novo Nordisk A/S. As a Clinical Trial Operations Manager, you will be responsible for overseeing the submission of clinical trials to regulatory authorities worldwide.

The successful candidate will have extensive experience in project management, with a strong focus on quality and compliance. You will work closely with cross-functional teams to ensure timely and compliant submissions.

  • Leading the CTA submission process effectively and applying best practices to ensure timely submission of CTAs.
  • Ensuring CTA submission is in compliance with all applicable requirements worldwide and driving better practice and consistency across trials.
  • Coordinating the preparation and monitoring the compilation of CTA documents for submission of initial CTAs and amendments.


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