Cipla Hiring for Regulatory Affairs @Maharashtra

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

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