Kathryn Moore, MS

Kathryn Moore, MS

Regulatory Project Manager

Ms. Moore joined Biologics Consulting in March 2016 and has over six years of drug/medical device industry expertise, including five years of management experience at contract research organizations. She has direct experience in regulatory consulting, authoring of regulatory submissions, study coordination, and quality control. Ms. Moore also has experience in nonclinical and clinical research and currently provides regulatory project management support to Sponsors regulated by CBER and CDER. She supports the organization of product development source information into clear, comprehensible applications, including Investigational New Drug (IND) applications (Phase I through Phase III), marketing applications (BLA/NDA), abbreviated and biosimilar marketing applications (505b2, ANDA, 351k), Master Files, Orphan Drug Designations, RAC submissions, and amendments and supplements, as needed.

Ms. Moore serves as the U.S. Agent Representative for many Sponsors. As U.S. Agent, Ms. Moore interfaces with CBER and CDER staff 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. Moore has extensive experience in legacy and eCTD-formatted applications. She is cross-trained in electronic publishing requirements and can advise Sponsors of best practices to implement during authoring to later support the electronic submission and life-cycle maintenance of applications.


Education

MS, Regulatory Affairs, George Washington University, Washington, D.C. (2018)

BA, Chemistry, Virginia Tech, Blacksburg, VA (2007)