ORGANISATIONAL OVERVIEW
Lambda Therapeutic Research is a global full-service Clinical Research Organization headquartered in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies worldwide.
Our team of over 1500 professionals across the globe delivers full-spectrum clinical trial solutions powered by more than 20 years of service to the industry.
POSITION DETAILS
Role: Regulatory Affairs Associate
Company: Lambda Therapeutic Research
Location: India (Ahmedabad / Mehsana)
Department: Regulatory Affairs
Experience: 1–4 years in CRO regulatory affairs with exposure to CDSCO submissions
Education: Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field
Employment Type: Full-time
ROLE OVERVIEW
Regulatory approvals are the gateway to every clinical trial. Before a study can begin, before a single patient is enrolled, regulatory authorities must review and approve the submission.
The Regulatory Affairs Associate ensures this process runs smoothly and efficiently across multiple regulatory pathways.
You will prepare and file Ethics Committee applications, manage eTMF documentation, handle zonal and central office submissions, coordinate CTRI registrations, and maintain regulatory trackers. You will work closely with internal teams and external stakeholders to ensure submissions are complete, compliant, and submitted on time.
Your work directly enables clinical trials to proceed and remain compliant throughout their lifecycle.
KEY RESPONSIBILITIES
Ethics Committee Submissions
Prepare and file Ethics Committee applications. Follow up for approvals and circulate them to relevant stakeholders.
eTMF Management
Upload regulatory documents to the electronic Trial Master File system. Review documents for accuracy and completeness. Maintain document integrity within the eTMF.
Zonal Office Submissions
Prepare regulatory dossiers for zonal offices. Draft justification notes as required. Coordinate with the respective teams to ensure timely submissions.
Central Office Submissions
Handle BE-NOC (Bioequivalence No Objection Certificate) applications. Manage TL (Trial License) applications. Prepare and submit CT (Clinical Trial) applications. Coordinate with relevant authorities and follow up for approvals.
Controlled Substances Applications
Prepare and submit dossiers for controlled substances to CBN/NCB. Follow up for approvals. Ensure compliance with controlled substance regulations.
CTRI Registration
Prepare and submit CTRI (Clinical Trials Registry India) applications. Coordinate with CT Project Managers on registration requirements. Follow up for registration approval.
Query Management
Draft responses to regulatory queries. Coordinate with internal teams to gather required information. Update status trackers with query progress and resolutions.
Reporting
Prepare departmental monthly reports on RA activities. Circulate reports to relevant stakeholders.
Audit Support
Assist during system and vendor audits. Prepare responses to audit observations. Support audit readiness activities.
REQUIREMENTS
Experience
1–4 years in CRO regulatory affairs with exposure to CDSCO submissions.
Technical Knowledge
CDSCO regulations and requirements. ICH-GCP guidelines. Schedule Y requirements. CTRI registration process. Dossier preparation. eTMF systems. Regulatory trackers and documentation.
Soft Skills
Strong written and verbal communication in English. Excellent coordination and collaboration abilities. Attention to detail and accuracy. Ability to manage multiple tasks and deadlines. Problem-solving approach to regulatory challenges. Proactive mindset.
REGULATORY PATHWAYS YOU WILL MANAGE
Ethics Committee
Applications, follow-up, and approval circulation for studies requiring ethical review.
eTMF
Uploading, reviewing, and maintaining regulatory documents in the electronic Trial Master File.
Zonal Offices
Dossier preparation, justification notes, and coordination with zonal regulatory authorities.
Central Offices
BE-NOC, Trial License, and Clinical Trial applications with central regulatory authorities.
Controlled Substances
CBN/NCB dossiers and follow-up for approvals related to controlled substances.
CTRI
CTRI registration applications, coordination with Project Managers, and follow-up for approvals.
Regulatory Queries
Drafting responses to queries from regulatory authorities and maintaining query trackers.
Monthly Reporting
Preparation and circulation of departmental monthly activity reports.
Audit Support
Assistance during system and vendor audits, including response preparation.
A TYPICAL WEEK IN THIS ROLE
Monday
Prepare an Ethics Committee submission package for an upcoming study. Upload recently approved documents to the eTMF.
Tuesday
Draft a response to a regulatory query received from CDSCO. Coordinate with the clinical team to gather supporting information.
Wednesday
Follow up on a BE-NOC application pending with the central office. Update the regulatory tracker with the latest status.
Thursday
Meet with a CT Project Manager to discuss CTRI registration requirements for an upcoming trial. Begin preparing the application.
Friday
Compile data for the monthly RA activity report. Assist with preparations for an upcoming vendor audit.
KEY STAKEHOLDERS
Ethics Committees
CDSCO (Central Drugs Standard Control Organization)
Zonal and Central Regulatory Offices
CT Project Managers
Clinical Operations Teams
Quality Assurance
Auditors
CBN/NCB (Controlled Substances Authorities)
CTRI
WHY LAMBDA THERAPEUTIC RESEARCH
Global Reach
Join a CRO with operations across India, USA, Canada, Spain, UK, and Poland. Your work will support clinical trials conducted worldwide.
Industry Leadership
Lambda has over 20 years of experience serving innovator, biotech, and generic pharmaceutical companies. You will learn from industry veterans.
Comprehensive Exposure
Work across multiple regulatory pathways—Ethics Committees, CDSCO, controlled substances, CTRI. Build deep regulatory expertise.
Career Development
Lambda offers clear pathways for professional growth. Opportunities to take on increasing responsibility and develop specialized knowledge.
Collaborative Environment
Work alongside experienced regulatory professionals, clinical operations teams, and project managers who support your success.
Purpose-Driven Work
Your regulatory submissions enable clinical trials that bring new therapies to patients. Your work matters.
WHAT WE OFFER
Opportunity to work with a global CRO
Exposure to diverse regulatory pathways
Collaborative team environment
Professional development and growth
Purpose-driven work in clinical research
Competitive compensation
APPLICATION PROCESS
Submit your application through the Lambda Therapeutic Research careers portal.
The hiring team reviews all submissions.
Qualified candidates are contacted for an initial conversation.
Interviews are conducted with Regulatory Affairs leadership.
Decisions and offers are communicated in a timely manner.
TO APPLY
Please submit your resume highlighting your regulatory affairs experience. Include details of your CDSCO submission exposure. List your educational qualifications. Tell us why you are interested in joining Lambda Therapeutic Research.
Apply for the Regulatory Affairs Associate position at Lambda Therapeutic Research.
- Lambda Therapeutic Research is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees as we work together to deliver trusted clinical research outcomes globally.
