I am a broadly-experienced regulatory affairs professional, specializing in eCTD submissions, FDA interactions, and project management. In the last five years, I have contributed to the approval of three marketing applications. I have compiled hundreds of regulatory submissions, including multiple eCTD INDs and marketing applications. I have acted as the U.S. Agent and Regulatory Contact for several sponsors, and I've participated in many FDA interactions, including Advisory Committee meetings, Application Orientation meetings, End of Phase meetings, Pre-IND meetings, and Type C meetings. As a project manager, my experience includes conducting a quality assurance investigation into abnormal laboratory results in an ongoing clinical trial managing the collection, review, and reporting of distribution data for a marketed product and leading the effort to collect rare, hyper-immune plasma for the manufacture of a plasma-derived orphan product. Specialties regulatory affairs, regulatory strategy, eCTD submissions, document formatting, project management, labeling, FDA, biologic products, combination products, Pre-IND, IND, NDA, BLA, ESGread more ...read less ...
biotechnology
pharmaceuticals
business development
project management
linking the triangle
North Carolina State University
A Cleaner World
Associate Director
Director Of Regulatory Operations At Cato Research
Regulatory Associate Ii At Cato Research
Regulatory Associate At Cato Research
Project Coordinator At Cato Research
Investigator At Us Investigations
Manager At A Cleaner World
Regulatory Operations At Cato Research
Sr. Regulatory Systems & Operations Specialist At Bioventus
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