美時化學製藥股份有限公司

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學名藥開發, 法規管理

待遇面議

台北法規策略計畫(資深)專員
Regulatory Affairs (Sr.) Specialist

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職務介紹

– 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

職務條件

學歷要求

大學以上

科系要求

生物學相關、藥學相關、醫學技術及檢驗相關

語文能力

英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通

工作經歷

2年以上

工作技能

其他條件:
-Having experience in submission or variation in Taiwan is a plus.
-With CRO Background is a plus.
-Familiarity with Korean is a plus.
-Familiarity with Thai/Vietnamese is a plus.
-Having experience in submission in South Korea or the APAC region is a plus.