Associate Regulatory Affairs Executive

Job Information

  • Job Type:Full Time
  • Location:Pune, Maharashtra
  • Offered Salary:₹Up to 15 LPA(Per annum)
  • Posted:1 month ago
  • Experience:3-7
  • Industry:Pharmaceuticals
  • Qualification:Master's Degree
  • Openings:5
  • Degree:M.Pharm (Regulatory Affairs) / B.Pharm + PG Diploma in RA
  • Company Name:PrimeCore Finance

Pune, Maharashtra Pharmaceuticals

Job Description:

Manage regulatory submissions and approvals for pharmaceutical products.
• Prepare and submit CTD/eCTD dossiers to CDSCO, USFDA, EMA
• Liaise with regulatory authorities on queries and approvals
• Monitor regulatory changes and assess business impact
• Ensure GMP compliance of manufacturing facilities
• Maintain product registration records

Skills Required:
  • Drug Regulatory Affairs
  • CDSCO
  • USFDA
  • CTD Dossier
  • GMP
  • Product Registrations
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