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Regulatory Submission_Whitefield Bangalore

4 - 9 years

5 - 12 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  • Extend support on the compiling, submission and approval of Country Specific Submissions files for the responsible countries (NDA, LCM & post approval changes)
  • Participate and extend support during initial submission planning
  • Review & update the list of documents required for the submission (e.g., NDA, variation, tenders)
  • Manage compilation and preparation of regulatory documents, information, data technical files to
  • support approvals for new product registration, renewals and changes

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