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
Valuable knowledge of pharmaceutical regulatory requirements and documentation.
Practical experience in re

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🏢 Mmc pharmaceuticals
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