Role & responsibilities

Core Objective

The Regulatory & Compliance Specialist ensures that all products, manufacturing processes, documentation, and operations strictly adhere to USFDA (CFR 21), European, and international regulatory standards. This role drives product registrations, dossier prep, audits, and international market compliance.

Key Responsibilities

- US FDA Submissions & Listings: Manage NDC filings (OTC & Rx), Drug Establishment Registrations, and filings for GDUFA, OMUFA, and MoCRA. Maintain FEI and DUNS numbers.
- Cosmetic & OTC Compliance: Handle MoCRA cosmetic registrations, product listings, ingredient filings, and review artwork/labels against US FDA and US Cosmetics Act standards.
- Import & Agency Correspondence: Resolve FDA shipment holds at US ports with customs brokers. Author responses to FDA queries (IR, DRL, ECD, CRL) and handle controlled correspondence.
- Lifecycle Management: Manage post-approval submissions (Annual Reports, PADER, CBE-0, CBE-30, PAS) and track mandatory fees.
- Cross-Functional Coordination:



Serve as the regulatory liaison for QA, R&D;, Production, and external clients. Utilise SPL and eCTD software.
- Audits & Compliance: Support internal/external audits (USFDA, EU, cGMP) and conduct gap assessments.

Non-Negotiable Requirements

- Experience: Hands-on, practical US FDA regulatory experience (academic-only experience will not qualify).
- Core Knowledge: Deep working knowledge of 21 CFR and FDA correspondence.
- Proven Track Record: Direct experience with NDC filings/renewals and handling FDA port/import holds.
- Setting: Must thrive in a fast-paced, export-driven environment.

Technical Skills & Frameworks

- Global Frameworks: USFDA regulations, EU guidelines, and global cGMP.
- EU Directives: Familiarity with MDR, IVDR, REACH, CLP, or EU Cosmetics Regulations (depending on specific product line).
- Quality Systems: Understanding of QMS standards such as ISO 13485, ISO 9001, or ISO 22716.

📌 International Regulatory Affairs Manager (Delhi)
🏢 Vishwa Management Services
📍 Delhi