Stephanie Pierson, RAC

Stephanie Pierson has more than 25 years of experience in the health sciences industry. She leads the technical and business operations as well as business development of the Somerville, NJ office.  

During her career, Stephanie has had significant experience in developing and implementing regulatory strategy in support of pharmaceutical, biotechnology and combination products’ submissions in the US. She has experience supporting FDA interactions including preparation of meeting requests and briefing packages, leading rehearsals, and attending FDA meetings. She has interacted with FDA as US/Regulatory Agent on behalf of clients. 

Stephanie has substantial experience in assessing general regulatory, clinical, nonclinical and CMC documentation for completeness / applicability in support of regulatory filings, and has coordinated the submissions, responses to queries and approval of applications. She has worked on and prepared submissions and lifecycle for all types of regulatory applications, including INDs, NDAs, BLA and ANDAs.  

Stephanie worked for B&H Consulting Services, Inc. (B&H) in several different leadership roles prior to ascending to the role of company President which she carried until the merging of B&H with VCLS Inc. Now in the expanded organization she continues to lead the Somerville, NJ organization to assure optimal client support while aligning with VCLS Inc. business initiatives. 

Stephanie is a Regulatory Affairs Certified (RAC) professional and holds a bachelor’s degree in science, from Cornell University, Ithaca, NY. Stephanie is a member of the Regulatory Affairs Professionals Society (RAPS).  

Prior to starting her regulatory career, Stephanie was an elite rower and sailor. She competed in US National, World Championship and Olympic competitions for rowing and the America’s Cup races for sailing.