Profile

Beate Schmidt, RAC

Benefits Regulatory Consulting

Contact Details

Benefits Regulatory Consulting
Gold Member
RegEx Pro

Bio

Drug development professional with 18+ years in the pharmaceutical/biotech industry and international regulatory agency (EMA) and in-depth experience in global regulatory affairs.

Position Title

  • Director
  • Manager

Education

European Business School (EBS)
Oestrich-Winkel, Germany
Market Access Manager (EBS) Certificate, 2016
Market Access
2015 To 2016

London School of Economics (LSE)
London, United Kingdom
MSc, 2014
Health Economics, Policy & Management
2011 To 2014

University Bonn
Bonn, Germany
Master of Drug Regulatory Affairs (MDRA), 2002
Drug Regulatory Affairs
2000 To 2002

Rupprecht-Karls-University
Heidelberg, Germany
MSc, 1996
Biology
1990 To 1996

Year Entered Profession

  • 1998

Current Organization Type

  • Self-employed Consultant

Job History

Regulatory Affairs Professionals Society (RAPS)
European Liaison
September 2013 - present

benefits - tailor-made regulatory consulting
Consultant pharma & biotech
Munich
January 2013 - present

European Medicines Agency (EMA)
Scientific Administrator
London
March 2009 - May 2012

Micromet AG
Director Regulatory Affairs
Munich
September 2007 - February 2009

Aspreva Pharmaceuticals
Associate Director, Global Regulatory Affairs
Victoria, BC
October 2004 - July 2007

Micromet AG
Head of Regulatory Affairs
Munich
January 1998 - September 2004

Regional Interests

  • Africa
  • Asia
  • AUSSI/NZ
  • Canada
  • Europe
  • United States
  • Worldwide

Product Interests

  • Biologics
  • Biotechnology
  • Combination Products
  • Innovative Pharmaceuticals
  • Orphan Products