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Key Responsibility
1. Registration planning
- Making plan registration (ie. new, renewal, variation) of assigned products.
- Co-ordinating with Commercial, Medical, Demand and above country in order to set up appropriate plan and strategy to be in line with business objectives.
2. Registration management and implementation
- To ensure that all new products are registered within the time-frame upon the launching schedule of commercial
- To ensure that renewals of the existing products are obtained timely for the supply continuity.
- To ensure that all technical changes are submitted and approved within in the time-frame upon the implementation.
- To ensure that all labelling updates are submitted and approved within the Target Submission Categoty (TSC) and aligned with the global prescription information.
- To ensure that promotional materials are verified and approved within the regulatory context and appropriate marketing key messages.
- Act as the Market Launch Change Coordinator (MLCC) to ensure artwork developed and implemented on-time without any mistake.
3. Regulatory consultation: To provide regulatory consultation and analysis based on experience, expertise, knowledge of local regulation and regulatory enviroment to line manager, other functional departments, above country.
4. Risk management: Periodically to identify and evaluate risks in the activities and operation of the departments and accordingly propose and take actions to mitigate impacts to the business operation and objectives.
5. Process improvements:
Continuously review and make the appropriate changes in order to improve the internal and cross-functional process.
6. QMS compliance and GSK policies.
7. Others: To take tasks as assigned by Heald of Regulatory Department.
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