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Ast. Manager/Manager/Sr. Manager - Regulatory Affairs (Clinical Trials) NMS Consultant

0.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Role: Responsible for regulatory activity related to clinical section for US, 'EU, WHO, Canada, Australia, New Zealand and South Africa Markets Key Responsibilities: ? 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...

Posted 1 day ago

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