Barbara Daniels

Barbara Daniels

Senior Regulatory Publisher

Ms. Daniels joins DRA with over 7 years of regulatory publishing experience. Most recently, she worked at Hikma Pharmaceuticals where, as a publishing team of two, she multi-tasked effectively to manage the submission workload of over 300 approved generic products and approximately 50 more in development. Prior to transitioning into Regulatory Operations, Ms. Daniels had 8 years of experience in Regulatory Affairs compiling and authoring documents for various types of regulatory submissions, including INDs, annual reports, meeting packages, ODD applications, and more. Ms. Daniels has also led validation activities while implementing new electronic systems; filled in as interim drug safety manager; and performed TMF audits. She has written numerous SOPs and work policies and enjoys finding ways to improve process efficiency while maintaining high-quality work product. Ms. Daniels holds a Bachelor of Science degree in Psychology from Clemson University.