Katherine Tyner

Senior Director, Regulatory Policy Leader, EMEA & CMC at Johnson & Johnson

Speaker

Dr. Katherine Tyner is the Senior Director, Global Regulatory Policy & Intelligence Leader EMEA and CMC for Johnson & Johnson. Katherine brings nearly 20 years of regulatory policy and regulatory science experience at the U.S. Food and Drug Administration, the Executive Office of the U.S. President, and the European Medicines Agency. Most recently, Katherine served as the U.S. FDA Liaison Official to the EMA. In that role she coordinated policy, standard, regulatory, and science activities between the two agencies.

Prior to her liaison role, Katherine served as a Senior Policy Advisor in the Office of Science and Technology Policy within the Executive Office of the U.S. President. In this role, she co-chaired the National Science and Technology Council for Lab-to-Market to improve the transition of innovations across the research-to-market continuum and established a new joint NSTC subcommittee to address chemicals of emerging concern, PFAS and related compounds, and national sustainable chemistry efforts.

Earlier in her career, Katherine was the Associate Director for Science in the Office of Pharmaceutical Quality. In this role, she drove policy initiatives as the lead of the CDER Nanotechnology Working Group. She also led the OPQ extramural research program and was the lead of a policy initiative, where regulations and guidances were pressure-tested for emerging manufacturing technologies, such as decentralized manufacturing.

Katherine holds a Ph.D. and M.S. in Chemistry from Cornell University and a B.A. in chemistry from Carleton College.