STEWART H. Mueller
head of regulatory affairs & quality
Mr. Mueller joined Tremeau in 2016 as the Consulting Head of Regulatory Affairs and Quality Assurance. Mr. Mueller is the Principal of SHM Pharma Consulting LLC and he brings more than 35 years of biopharmaceutical experience to guide Tremeau’s regulatory strategy and quality systems development. Mr. Mueller obtained more than 10 U.S. NDA and BLA approvals and over 175 global approvals in a variety of therapeutic areas and geographies.
Prior to joining Tremeau, Mr. Mueller spent 18 years with Sunovion Pharmaceuticals (Formerly Sepracor) as the Senior Vice President, Regulatory Affairs and Quality Assurance, responsible for establishing and managing both the RA and QA functions. Mr. Mueller also recently served as the Head of Global Quality Assurance for Sumitomo Dainippon Pharmaceuticals (Sunovion's parent company), responsible for the global quality and compliance system for the parent company and its affiliates.
Prior to his time at Sunovion/Sumitomo, Mr. Mueller held several roles of increasing responsibility in regulatory affairs and quality assurance with Rhone-Poulenc Rorer, responsible for small molecule projects, biologics, plasma-derivative products, and gene and cell therapy programs. Before Mr. Mueller joined the pharmaceutical industry, he spent 7 years working for the Food and Drug Administration and served as a Supervisory Investigator in the New York District Office.
Mr. Mueller holds an MBA in technology management from UOP, an MS in pharmaceutics from Temple University and a BS in geophysics from CCNY.