Speakers

Maria Burkholder is Senior Director, Biosimilars Regulatory Affairs at Teva Pharmaceuticals USA. In this role, Maria provides global regulatory strategy for biosimilar R&D projects and biosimilar and biologic post-approval programs. Over the past 14 years, Maria has provided regulatory support and strategy for numerous biologic, generic, and biosimilar programs at Teva including sterile products, complex generic products and drug-device combination products. Prior to Teva, Maria held various regulatory affairs positions at Abraxis BioScience, Spectrum Pharmaceuticals, Valeant Pharmaceuticals, and CUSTOpharm and holds a Bachelor’s Degree in Cognitive Science (Neuroscience/Neurobiology) and a Master’s Degree in Health Administration.