Lambda Therapeutic Research Ltd. is inviting applications for the position of Officer – Regulatory Affairs at its Ahmedabad headquarters. This is an excellent opportunity for pharmacy and life sciences graduates with 1–4 years of CRO regulatory affairs experience, particularly with CDSCO submissions, CTRI registration, and eTMF management.
If you are looking to grow your career in Clinical Research Organization (CRO) Regulatory Affairs, this role offers hands-on exposure to ethics submissions, BE-NOC applications, and controlled substance approvals.
📌 Job Overview
- Job Title: Officer – Regulatory Affairs
- Company: Lambda Therapeutic Research Ltd.
- Location: Ahmedabad, Gujarat
- Experience: 1–4 Years (CRO Regulatory Affairs)
- CTC Range: ₹3,00,000 – ₹5,00,000 per annum
- Qualification: B.Pharm / M.Pharm / Life Sciences
Lambda is a global full-service CRO with operations across India, USA, UK, Poland, Canada, and Spain, delivering end-to-end clinical research services to innovators and generic pharmaceutical companies.
🧾 Key Responsibilities
Regulatory Submissions & Approvals
- Preparation and filing of Ethics Committee (EC) submissions
- Handling BE-NOC, Test License (TL), and Clinical Trial (CT) applications
- Preparation and submission of CBN/NCB controlled substance dossiers
- Managing CTRI registration and coordination with CT Project Managers
- Zonal and Central office regulatory dossier preparation
Documentation & Compliance
- Uploading and reviewing documents in eTMF systems
- Drafting responses to regulatory queries
- Updating regulatory trackers and status reports
- Preparing and circulating monthly Regulatory Affairs activity reports
- Assisting in system and vendor audits with response documentation
This role demands strong understanding of CDSCO regulatory requirements, ICH-GCP, Schedule Y, and CTRI guidelines.
🎓 Educational Qualification
- Bachelor’s or Master’s degree in:
- Pharmacy (B.Pharm / M.Pharm)
- Life Sciences or related discipline
🛠 Required Skills
Technical Skills
- Experience with CDSCO submissions
- Knowledge of ICH-GCP, Schedule Y, CTRI requirements
- Proficiency in dossier preparation
- Hands-on experience with eTMF systems and regulatory trackers
Soft Skills
- Strong coordination and communication skills
- Fluency in English
- Attention to detail
- Ability to manage multiple regulatory timelines
💼 Why Join Lambda CRO?
- Exposure to global clinical research projects
- Structured regulatory affairs workflow
- International presence across 6+ countries
- Growth opportunities in CRO regulatory operations
- Competitive salary package (₹3–5 LPA)
For candidates aiming to build long-term careers in CRO Regulatory Affairs, CDSCO compliance, and clinical trial documentation, this role provides strong foundational exposure.
📩 How to Apply?
