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:
- Dossier Submission:
- Achieve timely submission of dossiers/DMFs and respond to deficiencies to ensure approvals for product launch.
- Post-Approval Variations:
- Submit variations to improve productivity, cost-effectiveness, and product quality.
- Maintain Product Marketing Authorization, renewals, and meet regulatory requirements.
- Document Maintenance:
- Update product dossiers as needed to align with internal changes and regulatory guidelines.
- Database Management:
- Update PRC/SAP-RA tables with registration details post dossier approvals.
- Regulatory Support:
- Provide regulatory support throughout the product lifecycle for smooth operations.
- Dossier Availability:
- Ensure dossiers are suitable and available for out-licensing and in-licensing.
- 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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