Hiring Regulatory Affairs executive.

Qualification: B.Pharm / M.Pharm / M.Sc. (Pharmaceutical/Chemistry) preferred.

Experience: 2–5 years of relevant experience in Pharmaceutical Regulatory Affairs and Dossier Preparation preferred.

Key Requirements:

- Strong hands-on experience in preparation, compilation, review and submission of regulatory dossiers.
- Experience in preparing CTD/eCTD dossiers and regulatory submission documents.
- Preparation of new product registration dossiers, renewals, variations and amendments.
- Good understanding of CTD Modules 1, 2, 3 and applicable regulatory requirements.
- Coordination with QA, QC, R&D;, Production and other departments for collection, review and compilation of dossier documents.
- Experience in handling regulatory queries,



deficiency letters and responses from regulatory authorities.
- Knowledge of CDSCO, State FDA, Drugs & Cosmetics Act/Rules and applicable pharmaceutical regulations.
- Knowledge of GMP and regulatory compliance requirements.
- Ability to review technical documents for accuracy, completeness and regulatory compliance.
- Good documentation, coordination and communication skills.
- Valuable knowledge of MS Office – Word and Excel.
- Experience in domestic and/or international regulatory submissions will be an added advantage.

Pay: ₹30,000.00 - ₹45,000.00 per month

Benefits

- Provident Fund

Work Location: In person

📌 Regulatory Affairs Executive (Nava Vadaj)
🏢 Gagar Foods
📍 Nava Vadaj