CDSCO Regulatory Affairs Specialist at JR Compliance Apply Now!
Job Details
- Company: JR Compliance
- Position: CDSCO Regulatory Affairs Specialist
- Location: Delhi / Mumbai
- Salary: ₹30,000 – ₹45,000 per month
- Experience Required: 1+ years
- Qualification: B.Pharm, M.Pharm, M.Sc, B.Sc, Life Sciences
- Application Mode: Email
Key Responsibilities
Regulatory Submissions – Manage CDSCO submissions for medical devices and cosmetics. Dossier Preparation – Prepare and review dossiers for registration and import licenses. Regulatory Compliance – Ensure compliance with EudraLex guidelines and pharmaceutical regulations. Product Lifecycle Management – Handle amendments, renewals, and change management. Sugam Portal Management – Use the Sugam Portal for submissions and approvals. License Acquisition – Obtain and maintain COS-2, COS-4, MD-15, MD-5, MD-9 licenses. New Registrations – Submit applications for new drug, medical device, and diagnostic kit approvals. Liaison with CDSCO/DCGI – Follow up on applications and resolve deficiency letters. GMP & Quality Compliance – Ensure adherence to Good Manufacturing Practices (GMP).
Eligibility Criteria
Education:
- B.Pharm, M.Pharm, B.Sc, M.Sc, Life Sciences, or a related field.
Experience:
- Minimum 1+ years in Regulatory Affairs for cosmetics or medical devices.
Key Skills Required:
Strong knowledge of CDSCO regulations & the Sugam Portal. Expertise in dossier preparation & submission requirements. Regulatory compliance for pharmaceuticals, medical devices, and cosmetics. Ability to handle multiple regulatory projects efficiently. Strong communication & problem-solving skills. Attention to detail for accurate submissions & industry compliance. Adaptability to evolving regulatory requirements.
Why Join JR Compliance?
Work with a leading regulatory compliance company.
Career growth opportunities in pharmaceutical regulatory affairs.
Competitive salary package (₹30K – ₹45K per month).
Exposure to CDSCO, GMP, and global regulatory standards.
Balanced work-life culture with challenging projects.
How to Apply?
Send your resume & cover letter to: hr@jrcompliance.com
Subject Line: Application for CDSCO Regulatory Affairs Specialist
Advance your career in Regulatory Affairs – Apply Today! CDSCO Regulatory Affairs Specialist at JR Compliance
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