Joy Sharp

About Joy Sharp

I am a highly motivated legal professional who is well-versed in complex project…

Experience

1. Counsel

   Exela Pharma Sciences Llc

   Sep 2023 — Present · Washington, DC, US

   With 15 years of experience in the Food and Drug Administration, Joy brings a wealth of specialized legal and regulatory knowledge to the table for regulated industry, particularly manufacturers of drugs, biologics, medical devices and combination products; importers of food and other regulated products; and companies seeking to optimize and market platform technologies, secure supply chains and meet quality expectations. Joy’s tenure with the FDA included service in CDER in OPQ\'s Ofc. of Policy for Pharmaceutical Quality and Office of Compliance; Ofc. of Food Policy and Response (Commissioner\'s Ofc.); CFSAN, Ofc. of Director; Ofc. of Regulatory Affairs, Office of [Enfcmt & ] Import Operations While at the FDA, Joy advised on many aspects of drug and biological product policy, including inspectional authority, product jurisdiction, statutory authority, and applicability of current regulatory regime to various Agency initiatives (e.g, FRAME (Advanced Manufacturing), platform technology designation program; quality metrics (QM)/ quality management maturity (QMM). Joy advised senior imports and field leadership in the areas of imports review process, sampling strategy, import alerts and administrative detention, prior notice, and ACE, e.g. Joy also supported implementation of FDA’s New Era of Smarter Food Safety, Food Safety Modernization Act, and FDA’s Strategy for the Safety of Imported Food.With her FDA regulatory experience, Joy provides insight on CGMP for small and large molecule drug product, drug substance/API, and excipient manufacturers, e.g, ICH quality guidelines, inspectional policy, recalls, PM reporting, QM/QMM initiatives, GGP, etc. For food and beverage industry, FSMA\'s foundational rules (PC, Produce Safety, FSVP, Accredited 3P Cert, VQIP, traceability, etc.)Prior to her work with the FDA, Joy spent nearly a decade as in-house transportation attorney (air freight-forwarding, ground carriage), e.g, as AGC for Walmart T&L in Bentonville, AR

Education

• The Johns Hopkins University

  Bachelor of Arts (B.A.), International Relations

  1986 — 1990

• University of Maryland School of Law

  Doctor of Law (J.D.)

  1990 — 1993

• The Johns Hopkins University

  Bachelor of Arts, International Relations