Regulatory Affairs Executive

2 weeks ago


Ambawadi Ahmedabad Gujarat, India HuminivexHires LLP Full time

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).

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

Work Location: In person



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