Synthetic Small Molecules Regulatory Role

3 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
Responsibilities

As a CMC Regulatory Expertise Opportunity, you will be responsible for:

  • Applying regulatory intelligence and establishing strategy for submission of clinical trial applications (CTAs) and marketing authorizations (MAAs)
  • Submission of regulatory files and responding to questions from health authorities
  • Ensuring the preparation, review, and submission of pre-meeting packages for health authority meetings as well as conducting rehearsals and participating in the meetings
  • Addressing process challenges by performing analyses and proposing new ways to support projects
  • Identifying phase-appropriate regulatory risks and developing mitigation strategies
  • Performing the regulatory assessment of planned or implemented CMC changes based upon global regulatory guidelines


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