Regulatory Affairs
Fast authority approvals for new products and changes to our existing portfolio
Regulatory Affairs ensures availability of high quality therapies to patients all over the world through rapid approvals of all Novo Nordisk’s products in the nearly 200 markets in which we operate.
We lead and support the processes around all authorisation applications and renewals. We give the company access to the marketplace by ensuring that we have sufficient documentation for licensing of our products and by developing scenarios for strategic decisions. We aim to be at the front line in spotting opportunities and challenging the guidelines that set barriers for marketing of Novo Nordisk’s products.
 | Regulatory Affairs is a fast-changing field, and the 400+ dedicated employees worldwide must possess negotiating skills as well as scientific insight to serve as Novo Nordisk’s representatives around the world. We strive to be responsive to the worldwide business needs of the company and we work closely with authorities and with our partners within Novo Nordisk to be able to navigate through the complex regulatory environment.
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See our other units in R&D
Diabetes Research Unit
Biopharmaceutical Research Unit
Device R&D
Global Development
CMC Supply
