Catarina Edfjäll is a Global Regulatory Affairs Expert with more than 25 years of experience in the biotech and pharma sector, now working as an independent consultant and mentor. She has profound drug development experience across the entire product lifecycle, from development to launch, and across many therapeutic areas, including rare diseases. She was responsible for the successful regulatory approval of 20 innovative medicinal products and new indications in more than 50 countries. In her most recent senior management role, Catarina was the global head of regulatory affairs at CSL Behring. Prior to that, she held leadership positions in regulatory affairs at companies formerly known as Actelion, Celgene and Shire, and, started her career at F. Hoffmann-La Roche.
Catarina is a Board Member at the Cancer Drug Development Forum (CDDF) and until recently she was also a board member at the International Collaboration on Rare Diseases & Orphan Drugs (ICORD) for more than 10 years, both non-profit organisations. She has been actively involved in several multi-stakeholder organisations, including the European Medicines Agency´s Committee for Orphan Medicinal Products´ Working Group with Interested Parties.
Catarina holds a Master in biotechnology engineering from the Ecole Supérieure de Biotechnologie in Strasbourg, a Ph.D. in biochemistry from the University in Basel and a Corporate Governance Certification from the Swiss Board School and the University of St Gallen.