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 MoCRA-related filings and renewals