面議(經常性薪資達4萬元或以上) 台北市信義區 2年工作經驗 5天前更新
- Evaluation of submission feasibility for in-licensed products (major) and domestically manufactured products in the APAC region (South Korea, Taiwan, Hongkong, Thailand, Singapore, Malaysia, Vietnam, Philippines, and Indonesia)
- Conduction of the dossier audit and production of the gap list
- Evaluation and plan of the design, the budget, and the timeline for the bioequivalence study, the bridging study, and the clinical study in South Korea and Taiwan
- Communication with the APAC regulatory team and partner company to resolve the submission gap in the target market
- Design and consolidation of the regulatory strategy of the key milestone, the submission pathway, the submission timeline, and the launch timeline in the target market
- Support of new submissions in Taiwan
- Dossier Compliance from CTD format to ASEAN format
- Update of the APAC regulations
- The other tasks
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