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.
Valuable 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.
Positive 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

Advantages:
Provident Fund

Work Location: In person

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