Regulatory Affairs Officer

Roles & Responsibilities
• Prepare and submit Ethics Committee (EC) applications and follow up for regulatory approvals
• Upload, review, and maintain regulatory documents in electronic Trial Master File (eTMF) systems
• Prepare and submit dossiers, justification notes, and applications to Zonal and Central regulatory offices
• Coordinate and support BE-NOC, Test License (TL), and Clinical Trial (CT) application submissions
• Prepare and submit CBN/NCB applications for controlled substances and track approval status
• Prepare and manage CTRI registrations in coordination with Clinical Trial Project Managers
• Draft responses to regulatory queries and maintain regulatory submission trackers
• Prepare and circulate monthly regulatory affairs activity and status reports
• Support system and vendor audits and prepare responses to audit observations
• Ensure compliance with CDSCO regulations, ICH-GCP, Schedule Y, and applicable regulatory guidelines

Qualification
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline

Experience
• 1–4 years of experience in Regulatory Affairs within a CRO or clinical research environment
• Hands-on experience with CDSCO submissions and clinical trial regulatory documentation

Skills
• Strong knowledge of CDSCO regulations, ICH-GCP, Schedule Y, and CTRI requirements
• Experience in dossier preparation, regulatory submissions, and eTMF systems
• Proficiency in regulatory documentation tracking and compliance monitoring
• Excellent communication, coordination, and documentation skills
• Strong attention to detail with the ability to manage multiple regulatory activities
• Problem-solving mindset with a proactive regulatory approach

About the Organization
Lambda Therapeutic Research Ltd. is a globally recognized Clinical Research Organization providing comprehensive clinical development and bioequivalence research services. Known for regulatory expertise and quality-driven clinical research, the company supports pharmaceutical and biotechnology clients across international markets.