As head of the Global Regulatory Affairs (GRA) within Janssen Pharma, Karin Van Baelen leads an organization of approximately 900 highly qualified colleagues who foster relationships with Health Authorities around the world and deliver innovative healthcare solutions to patients. Under her leadership, the GRA organization influences and interprets global regulatory requirements and enables our company to meet those guidelines. In addition, GRA oversees the development of regulatory strategy for products from all therapeutic areas, as well as the delivery of high-quality, on-time regulatory submissions and approvals. GRA also engages in policy development at national and international levels in the regulatory, biotechnology and clinical development arenas
Previously, Karin served as Vice President of Regional Regulatory Affairs and Global Regulatory Operations, leading activities in Europe, Middle East, Africa, Russia (EMEA), Asia Pacific and Latin America and overseeing the Labeling & Submissions Management organization. From 2008 to 2013, she led the EMEA Regional Regulatory Affairs team in all regulatory aspects for all therapeutic areas and all operating company regulatory organizations in the region. Karin also served as Vice President of Global Regulatory Affairs for Tibotec BVBA where she created and led its global regulatory team and contributed to the development and approvals of several products in the Janssen Infectious Diseases & Vaccines portfolio. She also worked with GRA at the Janssen Research Foundation and was responsible for the worldwide registrations of several key products, including medications for severe mood disorders and pain. Karin joined Johnson & Johnson in 1993 from Upjohn Benelux where she submitted numerous Marketing Authorization Applications and obtained approvals in Europe and emerging markets.
Karin has a strong record of developing successful leaders and served as the EMEA Diversity & Inclusion regional champion.
Karin obtained her Doctor of Pharmacy (Pharm.D.) degree at the University of Antwerp, Belgium in 1988. Karin serves with the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) Scientific Regulatory & Manufacturing Policy Committee (SRMPC) and with the Pharmaceutical Research and Manufacturers of America’s Regulatory Affairs Coordination Committee (RACC).