Kelly H. Reich, MS, RAC

Kelly H. Reich, MS, RAC

Regulatory Project Manager

Ms. Reich joined Biologics Consulting in July 2001 and has 10+ years of experience providing project management regulatory support to Sponsors regulated by CBER and CDER. This primarily includes helping Sponsors organize their product development source information into a clear, comprehendible application.

She supports the development of 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. Reich also assists with Establishment Registration and Product Listings as well as Generic Self-Identifications.

Ms. Reich serves as the U.S. Agent Representative for foreign groups as well as U.S. based companies who don’t have a regulatory group or comfort dealing with the FDA. In this capacity Ms. Reich regularly interacts with CBER and CDER project management staff and reviewers and attends FDA-Sponsor meetings, providing written meeting minutes. She is familiar with FDA regulations and guidances as well as preferences at CDER/CBER/OOPDs.

Ms. Reich has extensive experience working with both legacy and CTD formatted applications submitted on paper and electronically. She is cross-trained in electronic publishing requirements and can therefore advise Sponsors regarding best practices to implement during writing efforts to later support the electronic submission and lifecycle maintenance of the application.

Ms. Reich completed a MS in biotechnology and regulatory affairs at Johns Hopkins University in 2007 and achieved her Regulatory Affairs Certification (RAC) in 2010.


Education

MS, Biotechnology & Regulatory Affairs, Johns Hopkins University, Baltimore, MD (2007)

BS, Biotechnology, James Madison University’s College of Integrated Science and Technology, Harrisonburg, VA (2001)

CERTIFICATION

Regulatory Affairs Certification (RAC) (2010)