Robert L. Iser, M.S.

Robert L. Iser, M.S.

Robert L. Iser, M.S.

Vice President, Regulatory Consulting Services

Robert (Bob) Iser leverages his U.S. FDA and biopharmaceutical industry experience to provide technical leadership and expertise including development of global regulatory strategies on behalf of Parexel clients interfacing with Regulatory Agencies and through leading a team of global regulatory experts.

Work Experience

Prior to joining Parexel, Bob spent 14 years with the U.S. FDA (most recently as the Director of the Office of Process and Facilities in CDER) with experience in CMC review, pre-approval inspections, CGMPs, guidance & policy development, and training; and has also served on a number of ICH and USP expert working groups.

Before joining the FDA, he worked for seven years in the biopharmaceutical industry as a quality professional with both QC and QA functional experience; and support of product and process development, analytical method and process validation, as well as, commercial operations.

Education

Bob received his M.S. in Chemistry from Wright State University, Dayton, Ohio in 1996.

We are always available for a conversation.

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