2012 – today Heinrich Regulatory Affairs Consulting and Interim Management,
Munich and Kronberg i. Ts.
Director Drug Regulatory Affairs (self-employed)
11th client: XXX Pharmaceuticals International AG, Zürich, Switzerland
Strategy Lead RA Oncology
10th client: XXX AG, Basel, Switzerland
RA CMC management and strategies
9th client: XXX Pharmaceuticals Group plc, Munich & Berlin
RA management and strategies: MAH transfer
8th client: XXX Pharma GmbH & Co.KG, Munich
RA management, strategies and CMC
7th client: XXX Pharma GmbH & Co.KG, Stuttgart
RA management and strategies
6th client: XXX Biotech GmbH (biosimilar development), Munich
RA CMC, strategies and development
5th client: XXX GmbH (global production site), Austria
RA global CMC compliance project
4th client: XXX Deutschland GmbH (global production site), Frankfurt a.M.
RA management, CMC, global compliance check
3rd client: XXX Consumer Healthcare GmbH & Co. KG, Hamburg
RA management
2nd client: XXX Regulatory Affairs Services GmbH, Munich
RA strategies
1st client: XXX, GmbH, German subsidiary of a US biotech company, Munich
Interim Head of Pharmaceutical Affairs DACH (RA, QA, Customer Support, Interface to PhV)
2010 – 2012 Micromet GmbH, Munich
Director Regulatory Affairs, Head of RA Compliance and Intelligence
Division: Global Regulatory Affairs
2008 – 2010 Teva Pharma GmbH, Innovative R&D, Mörfelden-Walldorf
European RA Project Leader, Senior Manager European RA
Division: European Regulatory Affairs
2003 – 2008 Otsuka Frankfurt Research Institute, Clinical Research, Frankurt a.M.
Senior Manager European RA
Division: European Regulatory Affairs
1999 – 2003 Merck KGaA, Darmstadt
Manager RA
Division: Global Regulatory Affairs
1996 – 1999 Paul-Ehrlich-Institute, Langen
Pharmaceutical Assessor
Division: Hematology and Transfusion medicine
1994 – 1996 Nichols Institute Diagnostics GmbH, Bad Nauheim
Scientific marketing representative in-vitro endocrinologic diagnostics
1994 PhD (Dr.rer.nat) in Biochemistry at the Rheinische-Friedrich-Wilhelms University, Bonn
1990 Chemist (Diplom-Chemikerin) at the Rheinische-Friedrich-Wilhelms University, Bonn