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醫療器械注冊經理 2-5萬/月/月

Sonder Group

上海

本科
03-02 發布

職位信息

職位名稱：醫療器械注冊經理

類別名稱：

職位描述：

職位描述：Responsibilities:1.Be familiar with the update regulations and able to provide Regulatory strategic thinking and proposal for the new projects.2.Establish a thorough submission plan for each assignment within the timeline agreed by stakeholders3.lead team to develop and execute regulatory strategy for complex local manufacture products and maintain existing licenses4.Be the partner of local manufactures and BUs in a strategic level5.Obtain timely approval for new drugs and all other necessary approvals for the existing products maintenance6.Ensure regulatory/legal compliance of regulatory activities.7.Liaising with the relevant governmental bodies and regulatory provincial FDA, SFDA, CDE, NIFDCQualifications:1.Bachelor degree or above in life science2.At least 10 years of experience in pharmaceutical industry;3.At least 7 years related experience incl. 3~4 years’ experience in local manufacture drugs (multi-skills i.e. device and package material preferred)4.At least 3 years people management experience – ability to motivate team5.Excellent knowledge and competency in Drug registration and relevant technical guidelines6.Good relationship with CFDA and the relevant affiliates7.Good communication skill, creative thinking, teamwork spirit8.Able to work under pressure to meet tight timelines9.Proficient in English specially in written and spoken10.Good PC skills

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