Katherin Tsokasis the Regulatory Head of Regenerative Medicine and Advanced Therapy for Janssen Research and Development.
She is a Regulatory professional with almost 30 years of progressive experience in all stages of pharmaceutical development from early stage through commercialization, and several areas of regulatory affairs including pre-clinical, clinical, and chemistry, manufacturing and controls. Demonstrated ability to build partnerships and pathways that contribute to effective prioritization, management of broad range of responsibilities, and achievement of cross sector common goals. Manage and lead cross sector, cross functional, multi-level, multi-site, global teams and deliver results amid ambiguity, obstacles and constraints.
As the Janssen Regulatory Head of Regenerative Medicine & Advanced Therapy (RMAT), and the Johnson & Johnson Director of the RMAT Network, Katherine ensures global regulatory policy strategies contribute to and support development plans for RMAT products. Through the RMAT Network, she facilitates cross sector access to subject matter experts for diligence, external collaborations and projects. In addition, she represents Global Regulatory Affairs on the J&J First in Human Committee. Further, she leads a Real World Evidence (RWE) cross sector and cross function Regulatory Team focused on the use of RWE in regulatory decision making to develop and shape globally harmonized approaches to regulatory policy that will effectively support innovation and patient access via the use of RWE.
Katherine is active with the Alliance for Regenerative Medicine (ARM). She is a member of the ARM: Regulatory Committee for which she chaired from 2011 through 2015; Government Affairs, and Science and Technology Committees. She is a frequent speaker at advanced therapy conferences and is a collaborator on planning programs in advanced therapy.