JOB DESCRIPTION – REGULATORY AFFAIRS EXECUTIVE

Company: MMC Pharmaceuticals Ltd.
Position: Regulatory Affairs Executive
Department: Regulatory Affairs
Location: Chennai
Experience: 3–4 Years
Qualification: B.Pharm / M.Pharm preferred
CTC: ₹4.5–₹5.5 LPA, depending on experience and expertise

Job Summary

We are looking for a detail-oriented and experienced Regulatory Affairs Executive to manage regulatory documentation, product registrations, submissions, renewals, and compliance activities for pharmaceutical products.

Key Responsibilities
- Prepare, compile, review, and maintain regulatory dossiers and documentation.
- Handle product registration, renewal, variation, amendment, and related regulatory submissions.
- Ensure regulatory submissions are complete, accurate, and submitted within timelines.
- Coordinate with CDSCO, State FDA, and other applicable regulatory authorities as required.
- Monitor and track the status of regulatory applications and approvals.




- Respond to regulatory queries and coordinate with internal departments for required documents and information.
- Maintain regulatory databases, trackers, approvals, licenses, and certificates.
- Coordinate with QA, QC, R&D;, Production, Medical, and Marketing teams for regulatory requirements.
- Review product information, labels, artworks, packaging materials, and promotional materials from a regulatory compliance perspective.
- Monitor changes in applicable pharmaceutical regulations, guidelines, and requirements.
- Ensure timely renewal of licenses, registrations, certificates, and other regulatory documents.
- Maintain proper records of regulatory submissions, approvals, correspondence, and commitments.
- Support preparation of documents required for current product launches and regulatory approvals.
- Ensure compliance with applicable regulatory requirements and company procedures.

Required Skills
- Good knowledge of pharmaceutical regulatory requirements and documentation.
- Practical experience in re

📌 Executive Regulatory Affairs (Porur)
🏢 Mmc pharmaceuticals
📍 Porur