Kim Wolfram

Kim Wolfram serves as the Senior Director and Head of Global Regulatory CMC Biologics & Gene Therapy at Biogen, a position held since June 2006. In this role, Kim leads the regulatory activities supporting biologic and gene therapy products and oversees global regulatory strategies for both investigational and approved products. As Global Co-Chair of ReachOUT, Kim champions LGBTQ+ inclusion within the organization. Previous experience includes positions as Director and Associate Director at Biogen, where achievements include leading successful Phase 3 clinical trial support and managing global regulatory submissions across multiple countries. Kim began a career in quality assurance at Abbott Bioresearch Center and holds a Master’s degree in Drug Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences, as well as a Bachelor’s degree in Natural Science from Saint Anselm College.