Sherma Winston, BSc, MSc

Sherma Winston, BSc, MSc

Sherma Winston, BSc, MSc

Principal Consultant

Shema is a regulatory affairs professional with extensive experience developing successful regulatory strategies and development pathways for new product platforms and proposed product modifications. With 14 years of industry experience and dedicated expertise in the development of in vitro diagnostics (IVDs) and nucleic acid amplification tests (NAATs), she integrates regulatory knowledge with industry experience in development strategies, commercialization, and marketing.

Work experience

Prior to joining Parexel, Sherma served as the Associate Director of Regulatory Affairs at Becton, Dickinson and Company (BD), Integrated Diagnostic Solutions (IDS), in Maryland. While at BD, Sherma managed cross-functional regulatory teams in the US and EU to lead the preparation and filing of 25+ successful premarket submissions to FDA and other global health authorities. She was responsible for the management of the regulatory lifecycle of instruments and assays, which included development of regulatory strategy, negotiating with various regulatory agencies, authoring regulatory submissions, and labelling and promotional material review. Sherma has extensive experience in Class III, Class II and Class I IVDs in the US and is recognized as the subject matter expert for IVDs in the EU with experience in supporting Annex List B and Non- Annex II devices under IVDD and Class A, B and C devices under IVDR.

Education

Sherma has a MSc in Biotechnology from Johns Hopkins University and a BSc in Chemistry from University of Maryland, College Park MD. She also holds her US RAC Certification.

Connect With Me

We are always available for a conversation.

*  

We are always available for a conversation.

Submitting...

Communication Preference

Communication Preference