2011 – today
Heinrich Regulatory Affairs Consulting and Interim Management,
Pincipal Consultant Drug Regulatory Affairs (self-employed)
Client: MorphoSys AG, Munich
RA management (CMC development and LCM) and strategies
Client: SANOCHEMIA Pharmazeutika GmbH, Austria
Check RA processes
Client: Takeda Pharmaceuticals International AG, Zürich, Switzerland
Strategy Lead GRA: EU development: NS (early projects/EU landscape); GI (CP authorized: LCM and CMC); MAH merger and relocation
Client: Roche AG, Basel, Switzerland
Global RA CMC LC management and strategies
Client: Baxalta/Shire Pharmaceuticals Group plc, Munich & Berlin
RA management and strategies: MAH merger and relocation
Client: Puren Pharma GmbH & Co.KG, Munich
RA management, strategies and CMC
Client: Wörwag Pharma GmbH & Co.KG, Stuttgart
RA management and strategies
Client: Cinfa Biotech GmbH (biosimilar development), Munich
RA CMC and strategic drug development (FIH; first IMPD)
Client: Sandoz GmbH (global production site), Austria
RA global CMC compliance project
Client: Sanofi Deutschland GmbH (global production site), Frankfurt a.M.
RA management, CMC, global compliance check
Client: GSK Consumer Healthcare GmbH & Co. KG, Hamburg
RA management
Client: NDA Regulatory Affairs Services GmbH, Munich
RA strategies
Client: Alexion GmbH, Munich
Interim Head of Pharmaceutical Affairs DACH (RA, QA, Customer Support, Interface to PhV)
Permanent positions:
2010 – 2012 Micromet GmbH, Munich
Director Global Regulatory Affairs, Head of RA Compliance and Intelligence
Division: Global Regulatory Affairs
2008 – 2010 Teva Pharma GmbH, Innovative R&D, Mörfelden-Walldorf
European & Global RA Project Lead, 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 Life Science (Biochemistry) at the Rheinische-Friedrich-Wilhelms University, Bonn
1990 Chemist (Diplom-Chemikerin) at the Rheinische-Friedrich-Wilhelms University, Bonn