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 robust 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 product listings
Review and approve artworks and labels as per US FDA and US Cosmetics Act




Handle cosmetic ingredient listings and labeler code requests
Port & Import Compliance
Handle FDA shipment holds at US ports and coordinate resolution with customs brokers and FDA
Respond to FDA queries including IR, DRL, ECD, and CRL
Manage controlled correspondence and documentation with US FDA
Lifecycle & Ongoing Compliance
Manage post-approval lifecycle activities including Annual Reports, PADER, CBE-0, CBE-30, and PAS
Track and file OMUFA and other recurring compliance fees
Manage WDD and 3 PL registrations and renewals
Submit one-time marketing reports and CDER Direct Next Gen Portal reporting
Handle CMC and labeling-related queries from FDA
Support medicated animal feed facility registrations where applicable
Systems & Tools
Work with SPL and e CTD software for regulatory submissions
Maintain regulatory trackers, documentation, and compliance calendars
Customer & Internal Coordination
Act as regulatory point of contact for cust

📌 Regulatory compliance specialist (Ghaziabad)
🏢 Dabur India
📍 Ghaziabad