Regulatory Affairs job Available at Lambda Therapeutics | Apply Now for a Pharma job
If you are searching for a Regulatory Affairs Job in the clinical research industry, this Pharma Job opportunity at Lambda Therapeutic Research Ltd. could be the perfect next step in your career. The company is hiring an Officer in Regulatory Affairs at its Ahmedabad location. This Regulatory Affairs Job in a leading CRO offers professionals the chance to work on regulatory submissions, clinical trial documentation, and compliance activities while building a strong career in the global pharmaceutical research industry.
- Job Title: Officer
- Req ID: 1527
- Location: Ahmedabad, India
- CTC Range (INR): 300000 – 500000
About the Company
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization provides comprehensive end-to-end clinical research services to global innovators, biotech, and generic pharmaceutical industries.
With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda Therapeutic Research supports global clinical development through its advanced research capabilities and regulatory expertise.
Job Description
Lambda Therapeutic Research Ltd. is hiring for an Officer – Regulatory Affairs role. This Regulatory Affairs Job and Pharma Job involves handling regulatory submissions, documentation, compliance processes, and coordination with regulatory authorities. The role requires experience in CRO regulatory affairs with exposure to CDSCO submissions and clinical trial regulatory processes.
Key Responsibilities
- EC Submissions: Preparation and filing of Ethics Committee applications; follow-up for approvals and approval circulation.
- eTMF Uploading & Reviewing: Upload and review regulatory documents in the electronic Trial Master File system.
- Zonal Office Submissions: Preparation of dossiers, justification notes, and coordination with the respective team.
- Central Office Submissions: Handling BE-NOC, TL, and CT applications; coordination and follow-up for approvals.
- CBN/NCB Applications: Preparation and submission of dossiers for controlled substances; follow-up for approvals.
- CTRI Registration: Preparation and submission of CTRI applications; coordination with CT Project Manager; follow-up for registration approval.
- Query Responses and Tracker Updation: Drafting and coordinating responses to regulatory queries; updating status trackers.
- Departmental Monthly Reports: Preparation and circulation of monthly RA activity reports.
- System/Vendor Audits: Assist during audits; prepare responses to audit observations.
Qualifications
- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or related field.
Experience
- 1–4 years in CRO regulatory affairs with exposure to CDSCO submissions.
Technical Skills
- Knowledge of CDSCO, ICH-GCP, Schedule Y, and CTRI requirements.
- Proficiency in dossier preparation, eTMF systems, and regulatory trackers.
Soft Skills
- Strong communication and coordination abilities.
- Fluency in the English language.
- Attention to detail and ability to manage multiple tasks.
- Problem-solving and a proactive approach to regulatory challenges.
