Aleese Hopkins, MS
Regulatory Project Manager
Aleese Hopkins joined Biologics Consulting as a Regulatory Associate in October 2017 and has over 5 years of regulatory affairs experience. She provides project management and submission support for original applications and life cycle management, including INDs, BLA/NDAs, Orphan Drug Designations, and amendments and supplements as needed. She serves as a U.S. Agent Representative for foreign groups as well as a primary regulatory contact for U.S. based companies. In this capacity she facilitates communication between FDA and the sponsor and ensures requirements and timelines are adequately met. Ms. Hopkins has experience in eCTD formatting and is trained in electronic publishing, allowing her to advise Sponsors regarding best practices to implement during the writing process in order to support compliant electronic submissions of their application.
Prior to joining Biologics Consulting Group, Aleese was the Research and QA Associate for Aclairo Pharmaceutical Development Group, Inc. Here she gained experience in formatting, quality control, and technical writing. She is also trained in quality assurance and helped develop and run the QA department at Aclairo in order to perform TK analyses in accordance with GLP regulations.
Aleese holds a BS in Biology from Florida State University and a MS in Regulatory Affairs in Drugs, Biologics, and Medical Devices from George Washington University.
|Regulatory Affairs in Drugs, Biologics, and Medical Devices, George Washington University, Washington, D.C. (2020)
||Biology, Florida State University, Tallahassee, FL (2011)