CONCORD BIOTECH LIMITED
Hiring: Regulatory Affairs Specialist | Ahmedabad
📋 Job Details
| Position | Regulatory Affairs Specialist |
| Experience | 8 – 10 Years |
| Qualification | B.Pharm / M.Pharm |
| Location | Ahmedabad, Gujarat (Dholka / Limbasi) |
| Market | India & ROW (Rest of World) |
⚙️ Key Skills
- Indian regulatory requirements (FDCA, CDSCO)
- Dossier preparation for product registrations & manufacturing licenses
- WHO-GMP and emerging market regulations
- Technical review of BMR, BPR, Specs, MOA, Change Controls
- Cross-functional coordination
📌 Key Responsibilities
- Prepare & submit product registration documents (Form 25, 28)
- Handle WHO-GMP, State GMP, COPP, FSC applications
- Manage ROW market regulatory applications
- Liaise with F&D, QC, Production, QA teams
- Audit batch records, change controls, leaflets, artworks
Concord Biotech Limited | USFDA & EU-GMP Approved | Fermentation-based APIs
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