1 - 6 years
5 - 7 Lacs
Posted:2 days ago|
Platform:
On-site
Full Time
. Feasibility assessment/ new product evaluation
Literature review and BA/BE study designing
BE Study Monitoring
Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.)
Establishment and maintenance of study documents
Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.)
Review of BE study documents i.e protocol, reports, ICF etc.
Preparation/review of medical write up
Coordination for serious adverse event reporting and safety update to Regulatory agency
Torrent Pharmaceuticals
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