Lamda Research – Drug Regulatory Affairs Job openings for B pharm, m pharm & msc Candidates
LAMBDA Research Hiring for Regulatory affairs Professionals
Job Vacancies Details 2021
Department:Regulatory Affairs
Job Role: Officer/ Executive/ Sr. Executive
Job Code: RAEXAHDM
Qualification: M Pharma, B Pharma /MSC
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
About us
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
ca****@la********.com
Kindly mention job code in subject line while sending your CV.
Mode of Interview
Phone Interview
Video Call Interview
