Regulatory Affairs Executive – Pharmaceuticals

• Sr Executive/ Assistant Manager ( male preference )
• B Pharm/ M Pharmgraduate

• Preparation & submission of regulatory documents and ensuring compliance with Emerging & regulated markets.
• Handling queries related to dossier from clients & regulatory authorities.
• Review all documents as per Guidelines (ICH, WHO, Specific etc.)
• Ensure that all requirements meet the client & market requirements.
• Coordinating effectively with all cross functional terms to produce the documents required for compilation of dossiers.
• Create and manage the dossier plan(s)/ submission packages in line with the regulatory strategy.
• To reply the queries raised by clients or regulatory bodies for post approval changes.
• Review the technical documents (AMV, PV, BMR, SPEC STP and CDP etc) and legal documents.
• To handle responsibilities of legalization, aposillation and tracking for department purpose of legal documents (Product permission, certificate of pharmaceutical Product permission, FSC, Cover latter and Letter of authorization).

Job Type: Full-time

Pay: ₹45,000.00 - ₹55,000.00 per month

Work Location: In person