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Regulatory Affairs Executive
1 month ago
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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