Job i Storkøbenhavn
If you are passionate about drug development within Diabetes and Obesity and want to be a subject matter expert in a leading international organization, then this might be the job for you.
You will have the opportunity to take the lead and set the strategic direction in projects of crucial importance to Novo Nordisk’s growth on a global level.
Apply now for a life-changing career! The position
As a Regulatory Affairs Professional, you will have the opportunity to work within late-stage development, preparing for upcoming MAA/NDA/BLA submissions and roll out in the whole world.
You will be the voice of Regulatory Affairs CMC and you will be responsible for providing scientific and strategic input to the projects you work with to obtain the regulatory approvals. You will turn your knowledge within pharmaceutical operations into regulatory pathways and develop global regulatory CMC strategies based on current legislation and regulations.
You will be in the center of project planning and execution – responsible for planning, coordinating, and reviewing regulatory documentation related to the drug e.g., supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages. More specifically, you will be accountable for: