美時化學製藥股份有限公司
English Required
法規主任 Regulatory Affairs Section Lead
10/16 Updated
Full-time
Manager/Director
English RequiredSalary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
南投縣南投市
Required
Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
5年以上
Job Description
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.
9. Relocated in Nantou Operation Center for training for above 6months to a year.
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
生物學相關、醫學技術及檢驗相關、藥學相關
Work Schedule
09:00-18:00
Leave Policy
週休二日
Job Category
Other Legal Professionals
Biotechnology Research and Development Staff
Pharmaceutical Research and Development Staff
南投縣南投市
藥品製造業
美時化學製藥成立於 1966 年，是一個立足台灣、放眼國際的學名藥廠，目前為台灣營收規模最大的製藥公司，專注生產口服癌症用藥並銷售全世界。
美時以亞洲地區最頂尖的研發中心與生產設備，也是台灣唯一同時獲得美國 FDA、歐盟 EMA、日本 PMDA、中國 FDA 及巴西 ANVISA 認證的藥廠，全力以高品質、高近用性的藥物滿足未竟的醫藥需求，改善人類生活品質，致力為病患、員工與所有利害關係人創造最大利益。
透過目前足跡廣布台灣、韓國、泰國、越南、新加坡、香港、馬來西亞、菲律賓、與中國的直營市場，以及與一線藥廠成為合作夥伴，美時的高價值產品得以銷售至世界各角落，是少數能進軍所有國際市場的台灣藥廠。
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