Concord Biotech Limited is a R&D driven biopharma Company that manufactures Active Pharmaceutical Ingredients (API) through fermentation & semi-synthetic process and finished formulations. Concord, founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments.
Looking for a dedicated and experienced professional to join our Regulatory Affairs team.
Post : Regulatory Affairs Specialist
Qualification : B.Pharm / M.Pharm
Experience : 8 to 10 Years
Key Responsibilities :
• Submissions : Prepare, review, and submit product registration documents and manufacturing licenses (Form 25,28).
• Certifications : Handle applications for WHO-GMP, State GMP, COPP, and FSC certificates.
• Emerging Markets : Review regulatory applications for ROW (Rest of World) markets.
• Compliance : Manage life cycle applications and archival for FDCA, CDSCO, and Emerging Markets.
• Cross-functional Coordination: Liaise with F&D, QC, Production, and QA for submissions.
• Technical Review : Audit BMR, BPR, Specs, MOA, Change Controls, Leaflets, PIF, and Artworks.
Interested candidates, please share your CV on trushitacharya@concordbiotech.com with clearly mentioned position applied for in subject line.
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