– 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 recent 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 regulatory submissions and product registrations.
- Good understanding of CDSCO / State FDA requirements.
- Strong documentation and analytical skills.
- Excellent attention to detail and accuracy.
- Good communication and coordination skills.
- Proficiency in MS Word, Excel, and PowerPoint.
- Ability to manage multiple regulatory activities and meet deadlines.

Preferred Candidate Profile
- 3–4 years of relevant experience in Pharmaceutical Regulatory Affairs.
- Candidates with experience in product registration, renewals, variations, regulatory submissions, and dossier preparation will be preferred.
- Experience in handling regulatory authorities and cross-functional coordination will be an added advantage.

Compensation ₹4.5–₹5.5 LPA CTC, depending on the candidate's experience, knowledge, and suitability for the role.

Interested candidates can share their updated CV with the HR Department.

Pay: ₹450,000.00 - ₹550,000.00 per year

Benefits

- Health insurance
- Leave encashment
- Provident Fund

Work Location: In person

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