Job Title: Officer
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Job ID: 1527
Employment Type: Full-Time
Salary Range: INR 3,00,000 – 5,00,000 per annum
Experience Required: 1–4 years
Posted Date: March 3, 2026
About the Company
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The company provides comprehensive clinical research services to pharmaceutical, biotechnology, and generic drug companies worldwide. With operational facilities in India, the United States, Canada, Spain, the United Kingdom, and Poland, Lambda Therapeutic Research supports clinical development programs and regulatory processes across global markets.
Job Overview
Lambda Therapeutic Research Ltd. is seeking a qualified Officer to support regulatory affairs operations. The role involves managing regulatory submissions, maintaining compliance documentation, coordinating with regulatory authorities, and supporting clinical trial regulatory processes in accordance with applicable guidelines and standards.
Key Responsibilities
Prepare and submit Ethics Committee (EC) applications and coordinate follow-ups for approvals while ensuring proper documentation and circulation.
Upload and review regulatory documents in the electronic Trial Master File (eTMF) system to maintain accurate and compliant records.
Prepare regulatory dossiers and justification notes for zonal office submissions and coordinate with relevant internal teams.
Manage central office submissions including BE-NOC, Test License (TL), and Clinical Trial (CT) applications with appropriate follow-up for approvals.
Prepare and submit applications related to controlled substances such as CBN and NCB and monitor the approval process.
Coordinate Clinical Trials Registry of India (CTRI) registration including application preparation, collaboration with the Clinical Trial Project Manager, and follow-up for approval.
Draft and coordinate responses to regulatory authority queries and maintain updated regulatory trackers.
Prepare and circulate monthly regulatory affairs activity reports within the department.
Provide support during system or vendor audits and assist in preparing responses to audit observations.
Technical Skills
Knowledge of CDSCO regulations, ICH-GCP guidelines, Schedule Y, and CTRI regulatory requirements.
Experience in regulatory dossier preparation and regulatory submission processes.
Familiarity with electronic Trial Master File (eTMF) systems and regulatory tracking tools.
Soft Skills
Strong communication and coordination abilities.
Fluency in English with effective documentation skills.
Excellent attention to detail and organizational skills.
Ability to manage multiple tasks and work proactively in a regulatory environment.
Educational Qualification
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline.
Job Category: Regulatory Affairs / Clinical Research
How to Apply
Interested candidates can apply through the official careers portal of Lambda Therapeutic Research Ltd. or explore similar opportunities on ThePharmaDaily.com.
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