Joel Welch

Joel Welch is the Deputy Office Director for the Office of Product Quality Assessment III in the Office of Pharmaceutical Quality in CDER at the US Food and Drug Administration. The office performs product quality assessment for both small molecule API and biological products. He also served as the Rapporteur for the development of ICH Q5A(R2) and as the Chair for the Emerging Technology Program. Previously, he served as the Associate Director for Science & Biosimilar Strategy in the Office of Biotechnology Products. In that role, he served as a policy clearing official for the Office of Biotechnology Products and was also responsible for assessing emerging, complex, or precedent-setting issues of the office with particular emphasis on the biosimilar program. He has also served as a Review Chief, Team Leader, Primary Assessor, and Regulatory Project Manager. Prior to joining FDA, he spent 6 years in industry supporting late state analytical development of small molecule API.