Nikita McGee is a senior project manager of regulatory affairs for GRAS Associates, a NutraSource Pharmaceutical and Nutraceutical Services company with 17 years of regulatory affairs experience spanning the food (human and pet), pharmaceutical (human and vet), medical device and biologics industries. Authoring over 250 regulatory submissions as well as a book chapter, McGee offers a wealth of extensive regulatory knowledge. She is experienced in many aspects of regulatory affairs from project innovation through life cycle management, such as regulatory agency negotiations, regulatory intelligence, risk management, food safety compliance, inspections/auditing and facility registrations.