Lambda CRO Hiring Officer – Regulatory Affairs | 1–4 Years | Ahmedabad | Apply Now

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Lambda CRO Hiring Officer – Regulatory Affairs

Lambda Therapeutic Research Ltd

Ahmedabad

1–4 Years

Regulatory Affairs

CRO

₹3–5 LPA

🏢 About Lambda CRO

Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) with operations across India, USA, UK, Poland, Canada, and Spain. The organization delivers end-to-end clinical research services to innovators and generic pharmaceutical companies.

📌 Job Overview

• Position: Officer – Regulatory Affairs
• Location: Ahmedabad, Gujarat
• Experience: 1–4 Years (CRO Regulatory Affairs)
• Qualification: B.Pharm / M.Pharm / Life Sciences
• CTC: ₹3,00,000 – ₹5,00,000 per annum

🔬 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 & submission of CBN/NCB controlled substance dossiers
• Managing CTRI registration & 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 monthly Regulatory Affairs activity reports
• Supporting system and vendor audits with documentation

🎓 Eligibility & Skills

• B.Pharm / M.Pharm / Life Sciences degree
• Experience with CDSCO submissions
• Knowledge of ICH-GCP, Schedule Y, CTRI requirements
• Hands-on experience with eTMF systems
• Strong coordination & documentation skills
• Ability to manage multiple regulatory timelines

⭐ Why Join Lambda?

• Exposure to global clinical research projects
• Structured CRO regulatory workflow
• International presence across multiple countries
• Strong career growth in Regulatory Affairs
• Competitive salary package

📌 Note Before You Apply:
Ensure you have hands-on experience in CDSCO submissions, CTRI registration, and regulatory documentation before applying.

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