Regulatory Affairs Officer Jobs CRO Sector at Lambda Therapeutic Research
Professionals with experience in clinical research regulatory submissions now have a strong opportunity to grow their careers in the CRO industry. Lambda Therapeutic Research is hiring for the position of Officer – Regulatory Affairs at its Ahmedabad location. This role is ideal for candidates who have hands-on exposure to CDSCO submissions, ethics committee processes, and clinical trial regulatory documentation. Regulatory Affairs Officer Jobs
The position offers direct involvement in national regulatory activities and coordination with multiple stakeholders across clinical trial operations, making it a valuable role for professionals seeking long-term growth in regulatory affairs.
Company Overview
Lambda Therapeutic Research is a globally operating, full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization provides comprehensive end-to-end clinical research services to innovator, biotechnology, and generic pharmaceutical companies worldwide.
With operational presence across India, the United States, Canada, the United Kingdom, Spain, and Poland, Lambda Therapeutic Research supports global clinical development programs with strong regulatory, operational, and scientific expertise. The company is known for its compliance-driven culture and structured regulatory processes. Regulatory Affairs Officer Jobs
Job Location & Employment Type
- Job Location: Ahmedabad, Gujarat
- Employment Type: Full-time
- Industry: Clinical Research Organization (CRO)
- Department: Regulatory Affairs
Open Positions / Department Details
- Designation: Officer – Regulatory Affairs
- Requisition ID: 1527
This role is part of the Regulatory Affairs team supporting clinical trial submissions and approvals across India. Regulatory Affairs Officer Jobs
Key Roles & Responsibilities
The selected candidate will be responsible for managing and supporting regulatory submissions and related activities for clinical studies. Key responsibilities include: Regulatory Affairs Officer Jobs
- Preparation, submission, and follow-up of Ethics Committee (EC) applications
- Tracking EC approvals and circulation of approval documents to relevant stakeholders
- Uploading, reviewing, and maintaining regulatory documents in the electronic Trial Master File (eTMF) system
- Preparation of regulatory dossiers and justification documents for zonal office submissions
- Coordination with internal teams to ensure timely and accurate submissions
- Handling central office regulatory activities including BE-NOC, Trial License (TL), and Clinical Trial (CT) applications
- Preparation and submission of Controlled Substances dossiers to CBN/NCB and follow-up for approvals
- Preparation and submission of CTRI registrations in coordination with Clinical Trial Project Managers
- Drafting responses to regulatory authority queries and updating submission trackers
- Preparation and circulation of monthly Regulatory Affairs activity reports
- Supporting system audits and vendor audits, including preparation of responses to audit observations
Eligibility Criteria
Education
Candidates must hold one of the following qualifications:
- Bachelor’s degree in Pharmacy
- Master’s degree in Pharmacy
- Bachelor’s or Master’s degree in Life Sciences or a related discipline
Experience
- 1 to 4 years of relevant experience in Regulatory Affairs within a CRO environment
- Mandatory exposure to CDSCO regulatory submissions for clinical trials
Skills Required
Technical Skills
- Working knowledge of CDSCO regulatory processes
- Understanding of ICH-GCP guidelines and Schedule Y requirements
- Experience with CTRI registration and updates
- Hands-on exposure to dossier preparation and regulatory documentation
- Familiarity with eTMF systems and regulatory trackers
Soft Skills
- Strong written and verbal communication skills
- Ability to coordinate effectively with cross-functional teams
- High attention to detail and accuracy
- Capability to manage multiple submissions and timelines simultaneously
- Proactive problem-solving approach to regulatory challenges
Regulatory Affairs Officer Jobs
Salary & Benefits
- CTC Range: ₹3,00,000 to ₹5,00,000 per annum
In addition to competitive compensation, employees typically benefit from:
- Structured learning in global regulatory processes
- Exposure to international clinical research projects
- Professional growth in a regulated CRO environment
- Stable career progression opportunities
Final compensation will be determined based on experience and interview performance. Regulatory Affairs Officer Jobs
Selection Process
- Resume screening
- Technical interview
- HR discussion
- Final selection based on suitability and regulatory experience
How to Apply
Interested and eligible candidates can apply through the official recruitment channel of the company.
- Job Title: Officer – Regulatory Affairs
- Location: Ahmedabad, India
- Requisition ID: 1527
Candidates are advised to ensure their resumes clearly highlight CDSCO submission experience and CRO regulatory exposure. Regulatory Affairs Officer Jobs
Important Dates
- Job Posted On: February 2, 2026
- Application Status: Open
Why Apply for This Pharma Job?
This role provides a strong platform for regulatory professionals to deepen their expertise in Indian clinical trial regulations while working in a global CRO setup. Lambda Therapeutic Research offers exposure to diverse regulatory submissions, international standards, and structured compliance systems. The position is well-suited for candidates aiming to build long-term careers in clinical research regulatory affairs. Regulatory Affairs Officer Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Lambda Therapeutic Research or any of its group entities. All job details are shared strictly for informational purposes. Candidates are advised to verify information directly with the employer before applying. IndiaPharmaJobs.in does not charge any fees for job listings or applications. Regulatory Affairs Officer Jobs
Final Call-to-Action
If you have experience in CRO regulatory affairs and CDSCO submissions and are looking to advance your career in clinical research, apply now for the Regulatory Affairs Officer position at Lambda Therapeutic Research and take the next step toward professional growth in the CRO sector. Regulatory Affairs Officer Jobs
