Dr. Scott Wesselkamper, Director, Regulatory Affairs, is an experienced science professional with 20+ years of practice across academia, federal government, and industry, with the last four years in regulatory consulting. His regulatory affairs experience includes provision of regulatory strategy and advice, leading and participation in a variety of meeting types with the US Food and Drug Administration, Investigational New Drug application, Biologics License Application, and New Drug Application preparation, submission, and maintenance. Additionally, Dr. Wesselkamper has significant experience in 505(b)(2) drug products across many therapeutic areas and at all stages of development.
He received his BS in Biology from the University of Cincinnati and his PhD in Environmental Health Sciences from New York University. Prior to joining Premier Consulting, Dr. Wesselkamper was a Biologist with the US Environmental Protection Agency where he conducted qualitative and quantitative assessment of human health risks posed by environmental toxicants.