Thomas Kirchlechner

Thomas Kirchlechner, M.Sc., PhD
Vice-Chair, IGBA Biosimilars Committee

Director Regulatory Policy
SANDOZ

Dr. Thomas Kirchlechner is Director of Regulatory Policy in Sandoz Global Regulatory Affairs and has worked in pharmaceutical industry for 25 years. He has served in his current role for 6 years, which entails regulatory policy areas such as global harmonization of divergent regulatory requirements for biosimilars, by means of providing expert comments to biosimilar draft guidelines from around the world, in particular from Asia, Africa, Middle East and Latin America, and by running biosimilar workshops with health authorities or speaking at biosimilar conferences in these regions. Apart from his language proficiency in English and German (native) he is fluent in Spanish and Portuguese, which is vital for guideline review and speaking at health authority workshops and conferences in Latin America.

Prior to his policy role he was Group Head in the Sandoz Global Biosimilars Regulatory Affairs department, in charge of global submissions of the Sandoz biosimilars portfolio, preceded by Manager / Senior Manager roles in the same department focusing on submissions in EU, US, Japan, Canada and Australia.

Before joining Sandoz in Austria, he worked as deputy head of production at Dragenopharm, a pharmaceutical contract manufacturer in Germany.

Dr. Thomas Kirchlechner holds a Master of Science degree in chemistry from the University of Munich, Germany, and a PhD in chemistry, specializing in marine analytics, from Otago University in Dunedin, New Zealand.