Kelly H. Reich, MS, RAC

Kelly H. Reich, MS, RAC

Regulatory Project Manager

Ms. Reich joined Biologics Consulting in July 2001 and has 15+ years of experience advising sponsors on CBER and CDER regulatory requirements and providing application directed project guidance. This includes driving projects by educating first-time Sponsors and inexperienced teams regarding FDA regulations and expectations as well as integrating with a Sponsor’s existing infrastructure to manage global, multi-disciplinary teams working on applications for submission to FDA.

Supported applications include INTERACT, preIND, IND, BLA, NDA, ANDA, OD, DMF and related meetings. Ms. Reich coordinates and participates in writing, review, regulatory strategy discussions, generation and maintenance of project timelines, publishing and application life cycle maintenance activities (annual reports, fast track designation requests, protocol amendments, responses to FDA queries, etc.). She outlines typical application activities and milestones keeping in mind opportunities for accelerated pathways including fast track, breakthrough and regenerative medicine designations. And Ms. Reich provides perspective on best practices to manage availability of information, resources, corporate pressures, and publishing time to put together a quality application.

Ms. Reich has extensive experience serving as a regulatory contact or US Agent representative liaising with FDA on behalf of Sponsors. In this role she is in contact with FDA Regulatory Project Managers across various CDER and CBER offices on a daily basis following up on submission reviews, managing responses to information requests, and coordinating and participating in FDA meetings and associated rehearsals and de-briefing sessions.

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)