International Regulatory Affairs
Our International Regulatory team generates Market Authorisation Applications for Europe and many other countries in close collaboration with our local teams and is responsible for both assisting our subsidiaries and distributors to achieve the initial license approvals and following approval, for supporting the filing and approvals of lifecycle enhancements of our marketed products outside North America.
For our development programmes, the International Regulatory Affairs team is responsible for providing strategic input to the global clinical development teams about the regulatory climate in the EU and elsewhere, and for provision of regulatory advice to the teams. We are now conducting clinical development work in approximately 50 countries.
In all of our work, we collaborate very closely with the International Headquarters in Zug, Switzerland and the rest of the Global Regulatory team which are based in Cambridge, Massachusetts.