Robert Seevers

Background

About Robert Seevers

Bob Seevers brings over 40 years of experience in the pharmaceutical research and development. He has experience as an FDA reviewer/team leader, clinical investigator, and in industry. After more than a decade in Nuclear Medicine, Bob spent 8 years with FDA, followed by 16 years with Eli Lilly and Company in Quality Assurance and Regulatory Affairs. He has led the regulatory CMC submission strategy for drugs in preclinical development through their NDA/BLA submission and the approval process for both small and large molecules. He is now an independent regulatory consultant. Bob’s expertise includes cold chain shipping, stability, determining regulatory starting materials, radiopharmaceuticals, setting global specifications, determining product critical quality attributes, quality by design (QbD), global regulatory submissions, and interactions with regulatory agencies. His knowledge spans the therapeutic areas of Central Nervous System, Endocrine, Metabolism, Autoimmune, Oncology, and more. As a Senior Advisor, Bob is responsible for the development of the regulatory strategy for early through late-stage regulatory filings for both large and small molecules, interaction with global regulatory agencies, and leading cross-functional CMC development teams.