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Concord Biotech Limited Hiring Regulatory Affairs Specialist – Pharma Jobs in India

Concord Biotech Limited Hiring Regulatory Affairs Specialist – Pharma Jobs in India

chandrakanth April 7, 2026
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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

📧 How to Apply: Send CV to

hr@concordbiotech.com

📌 Subject line: “Regulatory Affairs Specialist”

Concord Biotech Limited | USFDA & EU-GMP Approved | Fermentation-based APIs
Post Views: 1

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