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Job highlights

Work/Life Balance

Time management

Flexibility

Problem Solving

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Positions Open for Regulatory Affairs Expert:

1. US Market – Post Approval

  • Experience: 3 to 6 Years
  • Qualification: M.Pharm (any specialization)
  • Key Skills:
    • Handling Post-approval Activities
    • CB-0, CB-30
    • PASS
    • FDA Inspections

2. US Market – CMC

  • Experience: 3 to 10 Years
  • Qualification: M.Pharm (any specialization)
  • Key Skills:
    • Filing ANDAs
    • Annual Submissions
    • Dossier Preparations

3. EU Market – Module 3

  • Experience: 3 to 10 Years
  • Qualification: M.Pharm (Pharmaceutics/Regulatory Affairs)
  • Key Skills:
    • CMC
    • Initial Submissions
    • Dossier Preparations
    • Pre/Post Submissions
    • Life Cycle Management (LCM)

4. EU Market – Module 1

  • Experience: 3 to 10 Years
  • Qualification: M.Pharm (any specialization)
  • Key Skills:
    • Administration
    • Preparation & Submission of Renewals
    • Response to Agency Queries
    • RSI & RFI

Job Location

APL Research Centre -1, Sy No. 313 & 314, Bachupally, Hyderabad

Application Details

For further details or to apply, please reach out to the provided email address before the application deadline.

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