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Looking for Regulatory Affairs Jobs in the clinical research sector? Lambda Therapeutic Research Ltd. is hiring an Officer – Regulatory Affairs in Ahmedabad, India. This life science job opportunity under Lambda Career is ideal for candidates, who want to build a career in clinical research, regulatory submissions, and CRO operations.
- Job Title: Officer
- Req ID: 1527
- Location: Ahmedabad, India
- CTC Range (INR): 300000 – 500000
About the Company
Lambda Therapeutic Research Ltd. is a global Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The company provides end-to-end clinical research services for innovator and generic pharmaceutical companies worldwide. With facilities in India, the USA, Canada, Spain, the UK, and Poland, Lambda supports global clinical trials and regulatory operations
Key Responsibilities
- Preparation and submission of Ethics Committee (EC) applications
- Handling CTRI registrations and regulatory approvals
- Preparation of regulatory dossiers and justification documents
- Uploading and reviewing documents in electronic Trial Master File (eTMF) systems
- Managing BE-NOC, TL, and clinical trial applications
- Drafting responses to regulatory queries
- Assisting in system/vendor audits and preparing audit responses
- Preparing monthly regulatory activity reports
Educational Qualification
Bachelor’s/Master’s degree in Life Sciences, or related field.
Experience
1–4 years in CRO regulatory affairs with exposure to CDSCO submissions.
Skills
- Strong communication and coordination abilities.
- Fluency in English language.
- Attention to detail and ability to manage multiple tasks.
- Problem-solving and proactive approach to regulatory challenges.
- Knowledge of CDSCO, ICH-GCP, Schedule Y, CTRI requirements.
- Proficiency in dossier preparation, eTMF systems, and regulatory trackers.
This opportunity through Lambda Careers at Lambda Therapeutic Research Ltd. is a great option. The role offers hands-on experience in clinical trial submissions, regulatory documentation, and CRO operations, making it ideal for candidates exploring Life Science Jobs in regulatory affairs. Professionals interested in clinical research and regulatory compliance can use this opportunity to build a strong career in the global CRO industry.
