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.
