Regulatory Affairs Executive

4 weeks ago


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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