天津招聘

工作内容：
1.Work for regulatory matters in China for Eisai global studies(including registration purpose global studies in China)interacting with Eisai global and local parties and relevant outside parties(SFDA/CDE,CROs ETC.).
2.Keep good communication with SFDA/CDE,CROs ETC.to be able to take efficient and flexible action.
3.Accumulate knowledge for regulatory works in China,and to share necessary information with Eisai local/global members.
4.Follow up any update for China regulation covering any trend/practice to be helpful for the global study works.
5.Contribute to set up regulatory strategy in/including China for Eisai global studies.
6.Primary contact in China for Eisai global study regulatory matters.
7.Interact with Eisai global/local regulatory parties to find the best approach for regulatory matters for Eisai global studies.
8.Prepare/review/ensure high quality regulatory document communicating with parties related to meet the target timeline.
9.Ensure regulatory works/procedures in compliance with relevant regulation and guidance in China.


招聘要求：
1.年龄：Lrrespective of age

2.学历：Bachelor’s degree required in scientific discipline(e.g.Medical,Pharmaceutical or any other lifescience area)

3.专业&经验：
Among the following Items below,1)2)[approplate work experiences] and 3) [English] are essential with some flexibility.Regarding 3) [English],no need to be super,but, any appropriate communication level would be required.
1)Around 5-10 years regulatory work experience.
2)Good experiences with SFDA/CDE.(e.g. Panel meeting experiences, ant good experiences with SFDA/CDE).
3)Any appropriate communication skill and experiences(teleconference and e-mail etc.)in English.
4)Good regulatory experiences for local and global studies in China(including registration purpose global study in China,hopefully)
5)CRO management experiences for regulatory dossier preparation works.
6)Good sense for quality and timeline.

性格：Calm,courteous,but vigorous (to achieve the goal trying to find ant good solution)

其他：Good complance ,Good teamwork spirit Stable person (not to change companies/location often)e.g. A married person,who has a family.

卫材药业（Eisai China Inc.）
卫材（Eisai）系世界知名医药跨国企业，本着“为人类健康保健服务-Human Health Care”的宗旨，于1996年在苏州工业园区投资成立了独资制药企业——卫材（中国）药业有限公司，其注册资本为3854万美元，总部设在上海，并已在全国设立了11个办事处和1个生产基地。目前，卫材在中国的产品主要涉及神经系统、消化系统、心血管系统等领域。
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