24 May, 2022
Experience: 2 – 4 years
1.Review the Study report (Clinical part) along with all appendices, final e-CTD report, as per SOP and applicable regulatory guidelines.
2.Review of SOPs, Project summary and other documents prepared by Medical affairs and pharmacovigilance team.
3.Ensure that necessary actions are taken for the rectification and all the findings/comments/suggestions are resolved.
4.Coordinate with Lead – Medical affairs and team for preparing new SOP as well as revising current SOP to upgrade the system.
5.Understanding of various regulatory requirements (Guidance) like USFDA, EMA, Canada, ANVISA, DCGI, TGA, NMPA, China, etc.
6.Review of sponsor comments, regulatory findings and ensure compliance to the same.
7.Perform any other duties as assigned by reporting head.
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