Shelly Engelhardt

Shelly Engelhardt is an accomplished regulatory manager with extensive experience in the pharmaceutical industry. Currently serving as Regulatory Manager for Labeling at Sagent Pharmaceuticals since December 2010, Shelly independently reviews and approves commercial labeling and ensures compliance with FDA regulations while managing multiple project timelines. Prior roles include RA/Labeling Specialist at Sagent Pharmaceuticals and QA Manager at deCODE chemistry, where Shelly established compliant quality systems aligned with industry standards. Additional experience encompasses QA Drug Supply Manager at Abbott, ensuring compliance of investigational product supply for clinical trials, and a long tenure at Searle/Pharmacia/Pfizer in various QA roles. Shelly holds a Bachelor’s degree in Business Management from National Louis University and an Associate's degree in Biology from Harper College.