Birgitte Jensen Schou

Sr. Regulatory Affairs Associate

Birgitte has more than 20 years of experience within regulatory affairs. Her main responsibility has been technical document and database support for a diverse range of regulatory submissions, e.g. CTA, IND, Orphan Drug Designation, PIP, authority meeting. At KLIFO, Birgitte supports our clients and internal team with submissions and updates in regulatory submission portals and related databases: CESP, CTIS, IRIS, Syncplicity and SPOR (SMS, PMS, OMS and RMS). In addition, Birgitte is a trained Clinical Trial Assistant with experience in Veeva Vault eTMF.