月薪65000~80000元 新北市中和區 1年工作經驗 5天前更新
【Responsibility】
1.Assist in preparation of applications for registration of new products, variations to marketed products and clinical trial applications.
2.Assist with responses to deficiency letters and other requests for data, e.g. local testing requirements.
3.Prepare safety update reports, certified product details and import permits.
4.Liaise with operations department and others to maintain product changes and ensure these comply with regulations.
5.Provide support, including local clinical study for marketing plans and launch teams.
6.Maintain good knowledge of the Code. Maintain contact with officials of the relevant parties.
7.Review labeling, over-labeling, product information, and promotional material to ensure compliance with relevant regulations and codes.
8.To assist the Quality system related affairs.
【Requirement】
- University degree in appropriate discipline.
- Minimum 1 year post university experience and 2 years industry experience regulatory affairs relevant.
- Good cross function communication and coordination skills.
- Proven project management skills.
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Ean Liu
Email:ean.liu@manpowergrc.tw
LINE :@356gezfb
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