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

南投法規(資深)專員
Regulatory Affairs (Sr.) Specialist

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職務介紹

1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory perspective.

2. Interpretation and Handling the regulatory technical query’s responses that were asked by Client and Authority during the due diligence or submission deficiency phase and provide the action plan or solution and scientific justification.

3. Responsible for evaluating the registration feasibility and mapping the global registration strategy for assigned new R&D products.

4. Cooperate and teamwork with R&D, technical, and RA PM on new R&D project technical challenges and complete the dossier till product approval.

5. Responsible for regulatory registration for export products and make sure all the documents are meet the authority’s requirements.

6. Responsible for deficiency response preparation to ensure our response meets the authority’s requirements.

7. Accurately follow the update of the registration regulation, and provide the regulation update to the team and training.

職務條件

學歷要求

大學、碩士

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

不拘

工作技能

不拘