Evan Richardson

Director, Regulatory Services

Evan Richardson brings 10 years of experience in regulatory affairs and operations to GlobalSubmit. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he’s specialized in project management, system implementation, eCTD submissions and organizational training.

linkedin_logo

Connect with Evan on LinkedIn

Prior to joining GlobalSubmit, Mr. Richardson fulfilled a number of responsibilities within the regulatory departments of Bioventus and Cato Research, both located in North Carolina’s Research Triangle Park area. His career achievements include a major role in the approval of 3 distinct marketing applications, hundreds of regulatory submissions (IND, NDA, BLA, and DMF) and a company-wide launch and implementation of a new document management system.

Mr. Richardson is no stranger to readers of GlobalSubmit’s eCTD Summit blog. His article Transitioning from Paper to eCTD published in September 2011 is one of the most popular articles in the history of the site.

Articles and Presentations

FDA eCTD Mandate: One Year and Counting, May 5, 2016

Placement of DMF Reference Letters, March 14, 2016

Rules for Submitting Electronic DMFs to FDA, Health Canada, January 14, 2016

Transitioning from Paper to eCTD, September 7, 2011

eCTD Publishing Best Practices, March 9, 2011

Awards and Affiliations

Member, North Carolina Regulatory Affairs Forum (NCRAF)