Beate Schmidt, MSc, MDRA, RAC (US, EU)

Regulatory Affairs Lead Europe

Novateur Advisor Since



Regulatory Europe


Therapeutics, Immunology, Oncology & Immuno-Oncology, Regulatory

Beate Schmidt brings a truly unique and global experience set to the role of Novateur’s Regulatory Affairs Lead for Europe. Her 17 years of experience in the pharmaceutical/biotech industry includes a position as Scientific Administrator at the Rheumatology, Respiratory, Gastroenterology, and Immunology (RGI), and Anti-infective Sections of the EMA, London, overseeing a wide variety of applications submitted to the agency — from initial marketing authorizations to life-cycle procedures, including variations and renewals. She has lived and worked in Germany, Canada, the US, and the UK. Prior to EMA, she was Director of Regulatory Affairs at Micromet (acquired by Amgen for $1.2 billion), as well as Associate Director, Global Regulatory Affairs at Aspreva (acquired by Vifor for $1 billion). Since 2012, Beate has worked as an independent regulatory consultant based in Munich, Germany. She has prepared scientific advice procedures and regulatory submissions, from development and initial marketing authorization to post-authorization procedures.

Novateur Newsletter

Subscribe to our newsletter for access to latest updates.

Resource Databases

Access Novateur news as well as FDA and Expert Databases.

Relevant Events

Check out conferences and events we are attending!