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Regulatory Affairs Executive

3 months ago

Delhi, Delhi, India Ipca Laboratories Limited Full time

Position :
ExecutiveDepartment : Regulatory AffairsLocation : Kandivali
  • West, MumbaiQualification
  • M Sc/ B Pharm/ M PharmExperience : 8 years and aboveRoleResponsible for activities related to own submission and support for contract manufacturing projects of Europe marketJob 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 dossiersResponding to agencies queries to facilitate product approvalReview of applications for post approval variations prepared by subordinates for adequacy and correctnessDatabase maintenance to keep track of submissions, grants and approvalsMonitoring site transfer activity & ensure timely submission of documentations & approvalProviding technical support to marketing managersBeing updated with the regulatory guidelines