LAMBDA Research Hiring for Regulatory affairs Professionals
Job Vacancies Details 2021
Job Role: Officer/ Executive/ Sr. Executive
Job Code: RAEXAHDM
Qualification: M Pharma, B Pharma /MSC
Experience: 5 to 6 years
- 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
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.
Lambda is looking for proficient and passionate professionals to be a part of its future growth story.
Interested Candidates Share Your Resume to below mentioned mail Id
Kindly mention job code in subject line while sending your CV.
Mode of Interview
Video Call Interview