Henrik Kim Nielsen
| Henrik K. Nielsen is currently Vice President for Global Regulatory Sciences at Novo Nordisk where he has held several leadership positions in Research, Product Development and Manufacturing in Denmark and USA. Since 2004 he has been with Global Regulatory Affairs in various leadership positions. In Henrik current role, he works internally on some projects in particular strategy for simultaneous submissions in China. Externally he provides the industry positions and practices to advocate patient and industry’s interests through trade and industrial associations. He represents Novo Nordisk as regulatory and biotechnology expert in a number of trade associations such as IFPMA and EFPIA where he is chair of the International Regulatory Expert Group. He also joined the ICH M4Q(R2) Expert Working Group as Topic Lead for EFPIA. He has presented and organized several international conferences on the topic of drug development and CMC. He has served on the Program Committee of several DIA meetings. Henrik has a background as M.Sc. Chemical Engineering from the Technical University of Denmark, Ph.D. in Biochemistry from University of Fribourg, Switzerland and holds an MBA from IMD in Switzerland. He has about almost 40 years’ experience in the pharmaceutical industry with an extensive knowledge of Regulatory strategy and Compliance as well as development and manufacturing. |