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Cipla

5 years

₹2.00 - ₹5.4 lac (Approx)

Maharashtra

B.Pharma, M. Pharm, Bsc or MSc

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Job Purpose:

  • Submit product documents to regulatory authorities in line with country-specific requirements.
  • Ensure approvals and market launch within stipulated timeframes.
  • Handle post-approval changes, document maintenance, and updates throughout the product lifecycle.

Key Responsibilities:

  1. Dossier Submission:
    • Achieve timely submission of dossiers/DMFs and respond to deficiencies to ensure approvals for product launch.
  2. Post-Approval Variations:
    • Submit variations to improve productivity, cost-effectiveness, and product quality.
    • Maintain Product Marketing Authorization, renewals, and meet regulatory requirements.
  3. Document Maintenance:
    • Update product dossiers as needed to align with internal changes and regulatory guidelines.
  4. Database Management:
    • Update PRC/SAP-RA tables with registration details post dossier approvals.
  5. Regulatory Support:
    • Provide regulatory support throughout the product lifecycle for smooth operations.
  6. Dossier Availability:
    • Ensure dossiers are suitable and available for out-licensing and in-licensing.
  7. Regulatory Authority Interaction:
    • Coordinate with regulatory authorities (EU, NZ & TGA) for submission activities and approval status.

Competencies/Skills:

  • Collaborate to Succeed
  • Innovate to Excel
  • Perform with Accountability
  • Lead with Empathy
  • Act with Agility
  • Strong Domain Knowledge
  • People Management

For more details visit the link :

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Cipla Hiring for Regulatory Affairs

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