
Williams W
FDA Regulatory Affairs Consultant
Habilidades

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Porfolio
Experiencia laboral
Senior Regulatory Compliance Specialist | Regulatory Consult Partners
Business • Tiempo completo
Apr 2023 - Present • 3 yrs 4 mos
Successfully managed end-to-end FDA cosmetic registration and mandatory MoCRA compliance portfolios for over 150+ domestic and international beauty brands. Served as the designated US Agent service representative for foreign manufacturing facilities, acting as the primary legal liaison for all official communications with the US Food and Drug Administration. Established an error-free protocol for acquiring FEI numbers (FDA Establishment Identifier) and configuring user accounts securely on the Cosmetics Direct portal and CDX network. Handled complex OTC registration frameworks, ensuring full compliance for over-the-counter drug products including sunscreens, acne treatments, and hand sanitizers through precise ingredient list and SPL submissions. Spearheaded corporate audits for safety review substantiation, ensuring client packaging, product labeling, and adverse event reporting processes aligned perfectly with federal mandates to eliminate the risk of customs holds.