Justin Uthup
About Justin Uthup
Justin Uthup is the Director of Regulatory Affairs at ANI Pharmaceuticals, Inc., where he has worked since 2021. With over 15 years of experience in the pharmaceutical industry, he specializes in analytical chemistry, quality control, and regulatory affairs.
Current Role at ANI Pharmaceuticals
Justin Uthup serves as the Director of Regulatory Affairs at ANI Pharmaceuticals, Inc., a position he has held since 2021. In this role, he oversees regulatory strategies and compliance, ensuring that the company's products meet all necessary regulatory requirements. His responsibilities include managing submissions for Abbreviated New Drug Applications (ANDAs) and post-approval supplements, which are critical for the commercial success of pharmaceutical products.
Previous Experience at ANI Pharmaceuticals
Prior to his current role, Justin Uthup worked at ANI Pharmaceuticals, Inc. as the Associate Director of Regulatory Affairs from 2019 to 2021. He also held the position of Manager, Regulatory Affairs from 2014 to 2019. During his tenure, he contributed to the regulatory submissions process and played a key role in supporting the company’s commercial activities through effective regulatory strategies.
Experience at Sandoz
Justin Uthup has extensive experience at Sandoz, where he held multiple roles over several years. He began as a Laboratory Data Systems Supervisor from 2005 to 2008, then transitioned to a Regulatory Affairs Associate from 2008 to 2009. He advanced to Senior Regulatory Affairs Associate from 2009 to 2012 and later became Team Lead from 2012 to 2014. His work at Sandoz involved regulatory compliance and team leadership in various capacities.
Education and Expertise
Justin Uthup earned a Bachelor's degree in Forensic Science from the University of Central Oklahoma, where he studied from 1996 to 2000. With over 15 years of experience in the pharmaceutical industry, he specializes in analytical chemistry and quality control. His expertise includes conflict management, team development, and the validation and administration of laboratory software, as well as providing Chemistry, Manufacturing, and Controls (CMC) support in a regulatory context.
Regulatory Affairs Achievements
Throughout his career, Justin Uthup has successfully compiled and filed numerous Abbreviated New Drug Applications (ANDAs) and post-approval supplements. His leadership in managing groups and projects in both laboratory and regulatory settings has contributed to the successful navigation of complex regulatory landscapes, supporting the advancement of pharmaceutical products.