Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad - India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA), Fargo (USA) and Canada (Toronto), with a collective workforce of more than 1500 employees.
Post : Officer/ Executive/ Sr. Executive
Department : Regulatory Affairs
Job Code : RAEXAHD
Qualification : M.Pharma/B.Pharma/M.Sc
Location : Ahmedabad
Experience : 5 to 6 years
Job Description
• Submission of study documents to Indian Regulatory authorities (DCGI) for BE NOC. CT NOC. T-license. CT-10, CBN. Notifications. Amendment etc. through Sugam portal
• Reporting of Serious Adverse Events (SAE) to regulatory authorities
• Responding to queries from DCGI on dossier application
• Tracking of the projects approval, acknowledgement copies of SAE and Notifications from DCGI
• Registration of trials to Clinical Trial Registry- India (CTRI)
• Perform feasibility of study conduct from regulatory perspective
• Coordination with different internal stake holders for Ethics Committee (EC) related work
• Submission of study documents to Independent Ethics committees & Institutional review board
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