Caroline Möller

Regulatory Affairs & Quality Manager
Pharmaceuticals
Hutman Diagnostics
Switzerland

Business Expert Business and Management
Biography

Caroline holds a Ph.D. in Molecular Biology with several years’ work experience in Medical Device- and Biotech industry. She received the “Manager Regulatory Affairs” at the TÜV SÜD Academy (Germany). Caroline worked for more than five years as Regulatory Affairs Specialist at the orthopaedic company DePuy Synthes (Johnson&Johnson), which develops, produces and markets worldwide implants and instruments for the surgical fixation of the human skeleton and its soft tissues. Key areas of her expertise: Compiling Technical Files for products to be CE-marked in close collaboration with cross-functional and international teams (USA and EU), defining Regulatory strategies of new development projects, Risk Management, Clinical Evaluations, Biocompatibility and Post Market Surveillance. Before working at DePuy Synthes, she hold the position of Head of Research Services at the Department of Biomedicine of the University of Basel and the University Hospitals of Basel and Basel-Landschaft. She was in charge of interdisciplinary functions and projects with the aim to optimize operational and administrative processes supporting medical researchers. Caroline started her professional career in the Biotech start-up company Covalys Biosciences AG as Staff Scientist in Research & Development. Covalys Biosciences AG commercialized multifunctional protein-tags for analytical methods in academic and pharmaceutical research. As project leader Biochemistry, she was responsible for the development of new products up to market launch. Caroline received her Ph.D. degree in 2004 from the University of Basel (Biozentrum) in Developmental Biology, Genetics and Cell Biology. In 2000, she graduated in Molecular Biology (Biology II) at the University of Basel.

Research Intrest

 Pharmaceutical Sciences

Global Scientific Words in Business and Management