Edwards was employed for 42 years in the pharmaceutical and life sciences arenas.
From 1990 to 2010, he held Regulatory Affairs positions of increasing responsibility at TAP/Takeda Global Research & Development Center, Lake Forest, Illinois. Between 1996 and 2010, he led the implementation and oversight of the esubmission paradigm. This resulted in TAP’s dominance in eCTDs during 2006-08, with TAP submitting more than half of all eCTDs sent to FDA.
Prior to his tenure at TAP, Edwards gained additional career experience as a Medical Review Officer at FDA, scientist at NIH, and a teacher and researcher in several university health-science settings.
During his time at TAP, Edwards was active in the Regulatory Affairs Professionals Society [RAPS], serving as President-Elect in 2003, President in 2004, and Chairman of the Board in 2005.
Since retirement, he has organized a consulting business for health care product companies and litigation professionals [FDAexpert@gmail.com]. More recently, Edwards has developed eSubmissions University, www.esubmissionsuniversity.com. The new organization is focused on teaching companies and individuals of limited resources how to make successful electronic submissions to the FDA.