HeeSun Smaldore

HeeSun Smaldore

Regulatory Project Manager

Ms. Smaldore joined Biologics Consulting in May 2016 with over nine years of regulatory affairs experience. She supports Sponsors with product development related to INDs, BLA/NDAs, Orphan Drug Designations and amendments and supplements as needed. She serves as the U.S. Agent Representative for Sponsors and interfaces with the FDA on a consistent basis and attends FDA-Sponsor meetings. She is familiar with FDA regulations and guidance, as well as policies and procedures at CBER, CDER, and OOPD.

Ms. Smaldore provides regulatory guidance, project management and submission support for original applications and lifecycle management. She has extensive submission experience in legacy, CTD and eCTD formatted applications. Her experience in electronic publishing allows her to advise Sponsors with the best practices to implement during writing efforts in order to support compliant electronic submissions and lifecycle management of an application.

Most recently, Ms. Smaldore was the Regulatory Affairs Manager at Aclairo Pharmaceutical Development Group, Inc. where she managed the regulatory services, including regulatory strategy and operations, project management and ongoing application maintenance. She served as U.S. Agent for foreign Sponsors as well as Authorized Representative for U.S. based companies needing regulatory support. In addition, Ms. Smaldore attended many FDA meetings, performed literature searches, assisted in writing and QC of nonclinical 2.6 sections and regulatory documents (briefing documents, IBs, annual reports, FDA waivers, regulatory strategy memos and position papers).

Prior to Aclairo Pharmaceutical Development Group, Inc. she was at Parexel as a document specialist where she gained experience in electronic publishing and managed regulatory submissions for various regulatory authorities. At CROfessionals, Ms. Smaldore was a regulatory affairs associate where she gained project management, regulatory writing and clinical trial experience.


BS, Biology, George Mason University, Fairfax, VA