NUR NADZIRAH BINTI CHE AHMAD

Regional support.

• Support for ASEAN countries by executing the savings plan, checking the spending projection from each month, and estimating savings over the fiscal year with each country. This should be cross-checked with the regional and global budget tracker.
• Performed a budget plan for FY2324 and FY2425 with each country by estimating the spending for the next year, travel and expenses, and additional vendors, and cross-checked with the regional and global budget tracker.
• Regulatory database support for ASEAN countries and Australia.
• Act as a SPOC person for ASEAN to execute all the projects involving database updates (i.e., data cleaning, labeling updates, dossier uploads), and as the system trainer for the new hire in ASEAN.
• CPP applications with TGA Australia for use of other countries' registrations.

Local support.

• Support to enable smooth day-to-day operations and timely high-quality delivery of programs in Malaysia.
• Support in providing options and strategic direction for innovations and variations in Malaysia.
• Performs regulatory affairs activities related to obtaining governmental approval for new products that are covered by government regulations, including the medicine advertisement applications (i.e., KKLIU approvals).
• Update regulatory databases (Veeva RIM, QualityOne, GTRAQ, Claims, PromoMats).
• Managed to create and complete the migration of dossiers from the old MAH to the P&G regulatory system in 3 months, which involved 47 products with 500+ dossiers and packaging artworks.

• Assist in the application of registration and ensure timely completion of new products and medical devices for overseas suppliers.
• Approvals of Medical Device Registration received for IVD and GMD medical devices in Class A, B, C, and D.
• Assist in GDPMD activities, collecting and maintaining the records.
• To perform recall activities by alerting sales/customers.