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Knut Zellerhoff, PhD, is a professional with more than 35 years of experience in the Pharmaceutical Industry. Following scientific training in chemistry (Goettingen University) initial tasks in the industry were devoted to synthesis and discovery of small molecules as potential candidates for drug development. He was promoted to the emerging area of project management in drug development and soon took over the combined responsibility for Project Management and Regulatory Affairs at Bayer AG, involving numerous new molecular entities for the treatment of cardiovascular, infective, inflammatory and metabolic diseases in all stages of development. He led numerous project teams in transitioning projects from local to global development or co-development with partner companies. Beyond the territories of particular interest like Europe, Japan and North America he helped all countries involved in the global development process according to their specific needs in achieving clinical trial permissions and marketing approvals. He made significant contributions to the development of tools and global organization of Project Management and Regulatory Affairs, both within the company and in international organizations. Dr. Zellerfhoff’s last positions at Bayer AG were Head of Pharma Project Controlling and Benchmarking and VP, Regulatory Affairs International/Global Regulatory. Fifteen subsequent years were devoted to consulting in the development of small synthetic molecules, biotechnology and botanical products with focus on CMC strategies/plans, documentation and regulatory processes.