Aron Stein , Ph.D., Regulatory Consultant

Dr. Stein is currently a consultant to the biotechnology industry.  He has over 20 years of pharmaceutical experience with demonstrated ability to lead, build, mentor, develop, and manage in both small and large organizations.  Broad areas of management responsibilities include Regulatory and Medical Affairs, and Quality Assurance.  Strategic FDA initiatives involved partnering with the Agency to develop CDER Guidance and reintroduction of marketed products.  Project specific regulatory strategies have led to rapid registration for multiple drug products.

Dr. Stein has functioned at the Vice President level in various regulatory and quality roles in companies, such as Isis Pharmaceuticals, Inc., Carlsbad, California, Abbott Laboratories, Chicago, Illinois, and Sequus Pharmaceuticals, Menlo Park, California.  Prior to that, he was the Director of Regulatory Affairs at Pfizer Pharmaceuticals and a manger of Regulatory Affairs with DuPont-Merck Pharmaceuticals.  Aron joined DuPont as a toxicologist in 1986.

Dr. Stein has an established track record of successful negotiations with regulatory authorities with multiple marketing approvals across a wide array of products and patient populations.

Aron earned a bachelor of science in biomedical sciences and a doctorate in toxicology from Texas A&M University, and was a NIEHS fellow at Kansas University Medical Center.