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

Regulatory Affairs Lead Europe

Novateur Advisor Since

2015

Field

Regulatory Europe

Specialties

Therapeutics, Medical Devices

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.

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