Lambda Therapeutic Research Job Vacancy For Regulatory Affairs Department
Department: Regulatory Affairs
Job Role: Officer/ Executive/ Sr. Executive
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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