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Lambda Therapeutic Research Ltd., a leading global Clinical Research Organization (CRO), is hiring a Regulatory Affairs Officer in Ahmedabad. This is an excellent opportunity for life sciences professionals with 1–4 years of experience in regulatory affairs and CDSCO submissions. Join a dynamic team managing ethics committee applications, CTRI registrations, and regulatory dossiers for global clinical trials.
Key Responsibilities
- EC Submissions: Prepare and file Ethics Committee applications; follow up for approvals.
- eTMF Uploading & Reviewing: Upload and review regulatory documents in electronic Trial Master File systems.
- Zonal & Central Office Submissions: Prepare dossiers, justification notes; coordinate BE-NOC, TL, and CT applications.
- CBN/NCB Applications: Prepare dossiers for controlled substances and follow up for approvals.
- CTRI Registration: Prepare CTRI applications and coordinate with Clinical Trial Project Managers.
- Query Responses & Tracker Updates: Draft responses to regulatory queries and maintain trackers.
- Departmental Reporting: Prepare and circulate monthly regulatory affairs activity reports.
- System/Vendor Audits: Assist audits and prepare responses to observations.
Qualifications & Skills
Educational Qualification:
- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or related field.
Experience:
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- 1–4 years in CRO regulatory affairs, with exposure to CDSCO submissions.
Technical Skills:
- Knowledge of CDSCO, ICH-GCP, Schedule Y, CTRI requirements.
- Proficiency in dossier preparation, eTMF systems, and regulatory trackers.
Soft Skills:
- Strong communication and coordination skills.
- Fluency in English.
- Detail-oriented, able to manage multiple tasks.
- Problem-solving mindset and proactive regulatory approach.
Benefits
- Competitive CTC: INR 3,00,000 – 5,00,000 per annum
- Exposure to global clinical research operations.
- Professional growth in regulatory affairs and clinical research.
- Collaborative and supportive work environment.
How to Apply
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