Susanne Heiland-Kunath

Company: Takeda Pharmaceuticals International GmbH

From June 2014 Susanne Heiland-Kunath is Head of Regulatory Affairs Europe, Vaccines Business Unit. She transitioned from heading Global Development Regulatory Therapeutic Area Immunology and Respiratory in Takeda. She has a working experience of more than 14 years in the field of international regulatory affairs for development products at Takeda. She has been involved in the development, approval and lifecycle management of products in different areas such as Gastroenterology, Respiratory and Immunology diseases, including the development of monoclonal antibodies in Rheumatoid Arthritis. She has gained substantial experience in European Scientific Advice procedures and FDA meetings for several development products, as well as in MAA submissions and approvals under the Centralised Procedure, Decentralised Procedure and Mutual Recognition Procedure. This includes the successful Rx-to-OTC switch of a gastroenterology product via the Centralised Procedure. She also has been involved in the MAA submissions and registration procedures in more than 70 countries for a key respiratory product at Takeda. She holds a PhD in Biology from the University of Konstanz, Germany. After her PhD thesis in Molecular Genetics she went to Beijing, China, with a scholarship by the DAAD for 1 year, which included working at Bayer Healthcare Beijing.