Nathalie Yanze-Vandenkoornhuyse

Nathalie Yanze-Vandenkoornhuyse has a diverse work experience in the field of regulatory affairs, starting from their role as an Associate Research Scientist at University Basel-Switzerland. Nathalie then worked as a Device Regulatory Affairs professional at Synthes before joining Roche Pharmaceuticals as a Technical Regulatory Manager. Later, they served as a Senior Technical Regulatory Program Director at Genentech, where they provided support for regulatory strategies in biotechnology and gained expertise in clinical product development and international regulatory environments. Currently, Nathalie holds the position of Senior Vice President, Regulatory Affairs at Coherus BioSciences, where they have taken on various roles such as Vice President Regulatory Affairs, Executive Director Regulatory Affairs, and Senior Director Regulatory Affairs. Nathalie has contributed to the successful launch and approval of biosimilar UDENYCA in the US and Europe and led the preparation of aTNF alpha biosimilar BLA. Throughout their career, Nathalie has utilized innovative regulatory strategies and effectively interacted with health authorities to address the challenges and meet the business needs in the field of regulatory affairs.

Nathalie Yanze-Vandenkoornhuyse received their Doctor of Philosophy (PhD) in Molecular Genetics from Michigan State University (USA) and Université de Lille I (France) between 1990 and 1994.