Lambda Therapeutic Research Job Vacancy For Regulatory Affairs Department

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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career@lambda-cro.com

Kindly mention job code in subject line while sending your CV.

Lambda Therapeutic Research Job Vacancy For  Regulatory Affairs Department