sharon

Junior Registration Coordinator

Global Marketing Services • Freelance

Jan 2023 - Present • 3 yrs 4 mos

Since establishing my independent consultancy, I have become a pivotal partner for global brands seeking to navigate the intricacies of the U.S. market. My primary focus is providing end-to-end FDA registration and FDA compliance solutions that eliminate the guesswork for international and domestic manufacturers. Global Registration Management: Successfully spearheaded over 200+ FDA registrations across the food, cosmetic, and medical device sectors. I manage the entire lifecycle of the FDA application, from initial DUNS number acquisition to final approval, ensuring zero administrative delays. Official US FDA Agent Representation: Currently serve as the designated US FDA Agent for dozens of foreign entities. In this capacity, I act as the authoritative liaison between the U.S. Food and Drug Administration and my clients, managing emergency communications and assisting during facility inspections. MoCRA Compliance Specialist: Achieved a 100% approval rate on complex registrations under the new Modernization of Cosmetics Regulation Act (MoCRA). I specialize in both cosmetic facility registration and electronic product listings, helping brands stay ahead of these recent legal mandates. Supply Chain & Import Optimization: I have streamlined the Prior Notice and import protocols for high-volume Amazon sellers. By implementing rigorous pre-shipment audits, I successfully reduced customs detention rates by 40%, saving clients thousands in storage fees and lost sales. Strategic Compliance Roadmaps: I develop bespoke compliance roadmaps for startups and SMEs, ensuring every product meets 21 CFR standards (including GMP and labeling requirements) well before their scheduled market launch. Audit & Warning Letter Resolution: I provide high-stakes support in responding to FDA Warning Letters and "Form 483" observations. My intervention has consistently helped businesses implement corrective actions, avoiding costly penalties and permanent import bans.