Ron Guido has been employed in pharmaceutical development since 1980, in the areas of Preclinical Screening, Clinical Research, Regulatory Affairs, Product Development and Quality Systems. These responsibilities have provided broad international and domestic regulatory and product development experience encompassing drugs, devices, biologics, and nutritionals. Collateral experience includes merger and acquisition, divestiture, product support and shareholder communication activities.
Specific, past project responsibilities encompassed transfer of international medical products through the U.S. regulatory process, to market, and the development and implementation of novel regulatory and development strategies to reduce lead-time to market. This included of assessment of international manufacturing sites, and development of CMC and manufacturing data packages in support of U.S. regulatory actions. Support of marketed products included coordination of advisory committees, application strategy for label enhancement and line extension, and development and support of advertising, promotion and labeling for new and marketed products.
He is currently Senior Director and Therapeutic Area Head for Cardiovascular Medicine – Worldwide Regulatory Strategy for Pfizer, Inc. Prior to joining Pfizer, he was employed by V.I. Technologies/ Precision Pharma Services, as Vice-President, Quality Assurance & Regulatory Affairs. He has held positions with Whitehall-Robins Healthcare, Fresenius Pharma USA, Ayerst Laboratories, Inc., and Mount Sinai Medical Center, New York.
His undergraduate education is in Biology and Psychology, and he holds an M.S. in Technical Communications from the Polytechnic University, New York.