Regulatory Aspects of Drug Development

Dr. Jonathon Parker is a pharmaceutical executive with over 30 years of experience in drug development. He is currently working at Ultragenyx, a biopharmaceutical company specializing in rare and ultra-rare diseases, as Vice President, Global Regulatory Affairs. His responsibilities encompass managing the global regulatory teams in developing registration strategies, dossier submission and defense, as well as health agency interactions worldwide for new drugs and biologics in the neurology therapeutic area and leading the global regulatory intelligence and policy function. Prior to Ultragenyx, Parker held various positions including: Vice President, Head of Global Regulatory Sciences at Cerevel Therapeutics; Vice President of Neuroscience Therapeutic Area at Takeda; and Senior Director, Global Regulatory Affairs at Pfizer. Parker has led the regulatory strategy and global development of over a dozen drugs including Trintellix, Lyrica, Chantix, DDAVP, and CombiPatch. Parker obtained a bachelor of science in pharmacy from Purdue University, a master of science in regulatory affairs and quality assurance from Temple University, and a doctor of philosophy in pharmaceutical sciences from the University of Rhode Island. He has published several articles on regulatory issues in various regulatory and pharmacy journals.