Senior Regulatory Specialist

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
Key Responsibilities
  • Contribute regulatory expertise to global strategies and tactics
  • Develop regulatory documentation for submission to Health Authorities globally, e.g., clinical trial applications, briefing packages, paediatric plans, and responses to health authority questions
  • Represent Global Regulatory Affairs in global clinical trial teams and other cross-functional teams
  • Collaborate effectively with cross-functional stakeholders such as project managers, medical and non-medical specialists, statisticians, and medical writers


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