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Regulatory Affairs
We ensure fast and competitive authority approvals for both new products and updates to the existing portfolio
Regulatory Affairs obtains the necessary licences to bring high quality therapies to patients and caregivers in the 190 countries in which Novo Nordisk operates.
Our main tasks are to:
- Provide the company competitive access to the global marketplace by ensuring optimal scientific documentation for licensing of our products
- Lead and support the processes around new product approvals, as well as the lifecycle management of our existing portfolio
- Engage in close dialogue with Health Authorities around the world to secure informed decision-making in all phases of the drug development process
Get to know Novo Nordisk Regulatory Affairs
Combining regulatory expertise with business understanding
Our 500+ dedicated employees worldwide possess negotiating skills, as well as scientific insight and serve as Novo Nordisk's representatives around the world when interacting with the regulatory agencies. We seek to match the business needs of the company and the requirements of the current and future regulatory environment.
We engage in close dialogue with Health Authorities across the globe to find optimal ways to guide our products through the complex and ever changing regulatory landscape.
Increasing complexity requires agile staff
In 1954, Novo Nordisk submitted a seven pages paper application for approval of three new products in Denmark.
In 2011, we submitted the Degludec and DegludecPlus applications to Health Authorities around the world. If we had printed the electronic submission to the US Food & Drug Administration (FDA) alone, it would have comprised 13.4 million pages, resulting in a stack of papers as high as 1,559 meters or close to twice the height of the world's tallest building – Burj Khalifa in Dubai.
The enormous escalation of our applications' sizes is a consequence of a massive increase in data requirements from the Health Authorities. Such a challenging work environment calls for highly skilled regulatory affairs professionals who are able to handle and oversee the complex dossier and sophisticated regulatory strategies required today for global submissions of medical products and devices.
