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Regulatory Affairs Executive

1 month ago

Delhi, India Ipca Laboratories Limited Full time
Position : Executive

Department : Regulatory Affairs

Location : Kandivali - West, Mumbai

Qualification - M Sc/ B Pharm/ M Pharm

Experience : 4 - 8 years and above

Role

Responsible for activities related to own submission and support for contract manufacturing projects of Europe market

Job Profile :

- To liaise with customers on matters related to their product licenses for implementation at the manufacturing site.- To liaise with stake holders for various technical documents and review it for accuracy as required for own EU submission and maintenance of customer MAs.- Discuss & Coordinate with R&D and Analytical development departments for finalization of technical documents, specifications etc.- Compilation of product dossiers- Responding to agencies queries to facilitate product approval- Review of applications for post approval variations prepared by subordinates for adequacy and correctness- Database maintenance to keep track of submissions, grants and approvals- Monitoring site transfer activity & ensure timely submission of documentations & approval- Providing technical support to marketing managers- Being updated with the regulatory guidelines

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