Asst. Manager/Manager/Sr. Manager-Regulatory Affairs

10 - 20 years

10 - 20 Lacs

mumbai navi mumbai mumbai (all areas)

Posted:16 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Responsible for regulatory activity related to clinical section for US, ;EU, WHO, Canada, Australia, New Zealand and South Africa Markets
  • Preparation of bioequivalence related sections of ANDA product dossiers as per current regulatory guidelines
  • Ensure timely preparation of amendments related to bioequivalence to expedite approvals
  • Review of BE protocol for all market including ROW market
  • Review of bio-waiver information and clinical strategy before start of clinical study.
  • Confirmation of reference product for EU countries for clinical study
  • Review and Preparation of 2.4 (non-clinical review) and 2.5 (clinical review) module for EU submissions
  • Review of SmPC, PIL, Labeling for US, EU and other markets with reference product to keep the generic product labeling up to date.

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