美時化學製藥股份有限公司

全職

學名藥開發, 法規管理

待遇面議

南投法規主任
Regulatory Affairs Section Lead

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職務介紹

1. Organize regulatory information and track and control submissions, review and advise on submission strategy for compliance with regulatory filings.

2. Evaluate new proposed change from operation team and assessment impact and requirement on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues and RA team.

3. Ability to provide clear direction and guidance to RA teams and others. To organize, prioritize, and deliver tasks and projects, with a sense of urgency. Ability to organize team works in timely manner with accuracy.

4. Represent Regulatory Affairs on project teams to ensure all regulatory requirements are met throughout the product lifecycle.

5. Regular update RA status in order to align with business objectives, deliver outstanding launches.

6. Keep closer communication with marketing team and related department proactively to get correct and immediate updates of our products. Need to ensure the variation not disturb the inventory.

7. Effective in working with multifunctional team and to fix complex matrices. Strong communication, interpersonal, organizational skills and problem solving skills.

8. Ability to provide clear direction and guidance to RA teams and others. To organize, prioritize, and deliver tasks and projects, with a sense of urgency. Ability to organize team works in timely manner with accuracy.

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

5年以上

工作技能

不拘