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Regulatory Affairs Executive
4 weeks ago
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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