The Regulatory & Compliance Specialist is responsible for ensuring that all products, processes, documentation, and business operations comply with USFDA , European , and other international regulatory requirements. This role supports product registrations, dossier preparation, audits, labeling compliance, and regulatory strategy for new and existing products of our Private label and Guar Gum business.
Job Highlights
Hands-on US FDA regulatory experience with strong knowledge of CFR 21
Manage NDC filings, FDA registrations, and compliance activities
Role & responsibilities
US FDA Submissions & Registrations
Manage NDC filings for OTC and prescription drug products, including annual renewals
Handle Drug Establishment Registration and facility compliance under CFR 21
Manage GDUFA, OMUFA, and Mo CRA-related filings and renewals
Request and maintain FEI and DUNS registrations
Cosmetic & OTC Compliance
Manage Mo CRA cosmetic facility registrations and produc...