S. Albert Edwards, PharmD, RAC, FRAPS

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.