1 Match for Evan Richardson from Apex, North Carolina, USA

Evan Richardson Age 89

Raleigh, NC | Apex, NC

Also known as: evan_r

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, ESG

• #North Carolina State University