Job Opening: Regulatory Affairs Specialist at Concord Biotech

Concord Biotech Limited is an R&D-driven biopharma leader specializing in Active Pharmaceutical Ingredients (API) and finished formulations. They are currently seeking an experienced professional to strengthen their Regulatory Affairs team.

Position Overview

Post: Regulatory Affairs Specialist
Qualification: B.Pharm / M.Pharm
Experience: 8 to 10 Years
Location: (Typically Ahmedabad/Gujarat-based, as per company headquarters)

Key Responsibilities

Category	Specific Tasks
Submissions	Prepare and review product registration documents and manufacturing licenses (Form 25, 28).
Certifications	Manage applications for WHO-GMP, State GMP, COPP, and FSC certificates.
Market Focus	Review regulatory applications specifically for ROW (Rest of World) / Emerging Markets.
Compliance	Lifecycle management and archival for FDCA, CDSCO, and Emerging Markets.
Coordination	Liaise with F&D, QC, Production, and QA for seamless submissions.
Technical Review	Audit BMR, BPR, Specs, MOA, Change Controls, Leaflets, PIF, and Artworks.

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How to Apply

If you meet the experience criteria and are looking to grow with a leading biotech firm, send your updated CV to the following contact:

Email: trushitacharya@concordbiotech.com
Subject Line: Must clearly mention the position applied for (e.g., “Application for Regulatory Affairs Specialist – [Your Name]”)

Note: Ensure your CV highlights your experience with ROW market submissions and CDSCO/FDCA compliance, as these are core requirements for this role.