Curriculum Vitae

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