Ms. Miller has more than 15 years of experience interpreting and applying regulatory guidelines in the Biotech and Pharmaceutical industry. Her experience includes providing leading leadership, regulatory strategy, project management for numerous INDs, NDAs, BLAs, and 510ks. She has participated in numerous FDA meetings (pre-submission, pre-IND, Type C Meetings, End of Phase 2 meetings) and provided annual GMP training to manufacturing employees. Ms. Miller has experience writing INDs, FDA meeting requests, briefing packages, and orphan drug designations, and managing gap analysis & due diligence projects. She has also served as US Agent for clients with both CBER and CDER regulated products. Prior to joining DRA, Ms. Miller was a Sr. Consultant at Parexel International, Regulatory Project Manager at FDA, as well as Sr. Quality Assurance Manager at Thermo Fisher Scientific. She has a MS in Bioscience Regulatory Affairs at Johns Hopkins University, Master’s Certificate in Project Management at George Washington University, and BS in Biology from University of Arkansas Pine Bluff.