Tanja Safinowski

Tanja Safinowski is a Senior Regulatory Affairs Advisor at Polpharma Biologics since June 2023, bringing extensive experience in regulatory affairs for biosimilar products, encompassing both pre and post-marketing authorization phases. Previously, Tanja held roles at Sandoz, including Senior Regulatory Affairs Manager and Regulatory Affairs Associate Manager, with expertise in marketing authorization application submissions and compliance with EMA regulations. Prior experience at Novartis Sandoz included managing clinical trial supply chains for biosimilar products, with a strong background in clinical trial supply planning and logistics. Tanja's career began at IKFE Institut für klinische Forschung und Entwicklung GmbH, where contributions included biomedical research and clinical research focused on endocrinology, along with validating bioanalytical methods according to FDA standards. Tanja holds a Master of Science in Biomedicine from Johannes Gutenberg University Mainz and a Bachelor of Science in Biosciences with Biomedical Sciences from Robert Gordon University.