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
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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

career@lambda-cro.com

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

Mode of Interview

Phone Interview

Video Call Interview