Regulatory Affairs Officer Job in Ahmedabad at Lambda Therapeutic Research Ltd. CRO role with ₹3–5 LPA salary. Apply now.
Regulatory Affairs professionals with experience in CRO operations now have an excellent opportunity in Ahmedabad. Lambda Therapeutic Research Ltd is hiring for the position of Officer in the Regulatory Affairs department. Candidates with 1–4 years of experience in CDSCO submissions and clinical regulatory processes can apply for this full-time role.
This position offers hands-on exposure to Ethics Committee submissions, CDSCO filings, CTRI registration, and regulatory documentation management within a globally operating Clinical Research Organization. Regulatory Affairs Officer Job in Ahmedabad at Lambda Therapeutic Research
Company Overview
Lambda Therapeutic Research Ltd. is a full-service global Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The company provides comprehensive clinical research services to innovator, biotechnology, and generic pharmaceutical companies worldwide. With international operational presence across India, USA, Canada, Spain, UK, and Poland, Lambda supports regulatory, bioequivalence, and clinical trial requirements across global markets. Regulatory Affairs Officer Job in Ahmedabad at Lambda Therapeutic Research
Job Location & Employment Type
- Position: Officer – Regulatory Affairs
- Location: Ahmedabad, India
- Employment Type: Full-Time
- Department: Regulatory Affairs
Open Position Details
- Requisition ID: 1527
- Posted On: 3 March 2026
- CTC Range: ₹3,00,000 – ₹5,00,000 per annum
This role focuses on regulatory submissions, coordination with authorities, dossier preparation, and compliance tracking within a CRO environment. Regulatory Affairs Officer Job in Ahmedabad at Lambda Therapeutic Research
Key Roles & Responsibilities
The selected candidate will handle multiple regulatory submission activities and coordination tasks, including:
Ethics Committee (EC) Submissions
- Preparation and submission of Ethics Committee applications
- Follow-up for approvals and circulation of approval letters
Regulatory Dossier Preparation & Submissions
- Preparation of zonal office dossiers and justification notes
- Handling central office submissions such as BE-NOC, Test License (TL), and Clinical Trial (CT) applications
- Coordination and follow-up with regulatory authorities for approvals
Controlled Substance Applications
- Preparation and submission of CBN/NCB dossiers
- Tracking and follow-up for necessary approvals
CTRI Registration
- Preparation and submission of CTRI applications
- Coordination with Clinical Trial Project Managers
- Follow-up for CTRI registration approval
eTMF & Documentation Management
- Uploading and reviewing regulatory documents in the electronic Trial Master File (eTMF) system
- Maintaining updated regulatory trackers
- Drafting responses to regulatory queries
Reporting & Compliance
- Preparation and circulation of monthly Regulatory Affairs reports
- Assisting during system/vendor audits
- Preparing responses to audit observations
The role demands accuracy, regulatory awareness, and efficient coordination with cross-functional teams.
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in Pharmacy
- Degree in Life Sciences or related discipline
Experience
- 1–4 years of experience in Regulatory Affairs within a CRO
- Practical exposure to CDSCO submissions is mandatory
Technical Skills
- Working knowledge of CDSCO regulations
- Familiarity with ICH-GCP and Schedule Y requirements
- Understanding of CTRI submission processes
- Experience in dossier preparation and regulatory documentation
- Hands-on exposure to eTMF systems and regulatory trackers
Soft Skills
- Strong communication and coordination abilities
- Fluency in English
- Attention to detail and documentation accuracy
- Ability to manage multiple tasks and deadlines
- Problem-solving mindset with proactive approach
Salary & Benefits
- Annual CTC: ₹3,00,000 – ₹5,00,000
Final compensation will depend on experience, regulatory exposure, and internal company policies.
Selection Process
The hiring process may include:
- Resume screening
- Technical interview focusing on CDSCO and regulatory submission knowledge
- HR discussion
- Final selection and offer
Shortlisted candidates will be contacted by the company for further evaluation.
How to Apply
Interested and eligible candidates should apply through the official company career portal or recruitment platform mentioning Requisition ID 1527. Applicants should ensure their CV highlights CDSCO submission experience, CTRI knowledge, and CRO regulatory exposure. Regulatory Affairs Officer Job in Ahmedabad at Lambda Therapeutic Research
Why Apply for This CRO Regulatory Job?
Regulatory Affairs professionals in CRO settings gain valuable exposure to diverse therapeutic areas and submission types. This role offers:
- Direct involvement in CDSCO and regulatory authority interactions
- Hands-on experience with CTRI, BE-NOC, and controlled substance submissions
- Exposure to audit processes and compliance management
- Structured career growth in Regulatory Affairs
- Opportunity to work with a globally operating CRO
For pharmacy and life sciences graduates aiming to build a strong career in regulatory submissions and clinical compliance, this position provides practical experience and long-term growth potential. Regulatory Affairs Officer Job in Ahmedabad at Lambda Therapeutic Research
Important Disclaimer
IndiaPharmaJobs.in is an independent job information platform that provides pharmaceutical and healthcare job updates for informational purposes only. We are not affiliated with Lambda Therapeutic Research Ltd or any other organization mentioned above. Candidates are advised to verify complete job details through the official company website before applying. Regulatory Affairs Officer Job in Ahmedabad at Lambda Therapeutic Research
Interested Regulatory Affairs professionals with CRO experience are encouraged to apply promptly and advance their career in clinical regulatory operations. Regulatory Affairs Officer Job in Ahmedabad at Lambda Therapeutic Research
