Kirsten Berger

Kirsten Berger serves as the Head of Global Labeling Strategy and Regulatory Affairs at Sobi - Swedish Orphan Biovitrum AB (publ) since April 2022, leading strategies for product labeling, including the development and maintenance of core labeling documents. Previously, Kirsten held positions at bluebird bio as Associate Director of EU Regulatory Labeling, Advertising & Promotion, and at Takeda and Shire in similar roles focused on international advertising and promotional regulatory affairs for rare hematology products. A significant tenure at Johnson & Johnson involved managing global marketing communications for diabetes care devices, showcasing expertise in regulatory review processes. Kirsten's academic background includes a Master of Science in Marketing from Mays Business School at Texas A&M University and various qualifications in Regulatory Affairs from institutions such as Ulster University and Universität zu Lübeck.