丁香人才 > 职位招聘 >医药公司/药店/医疗器械招聘 >上海医药公司/药店/医疗器械招聘 >徐汇区医药公司/药店/医疗器械招聘 >Regulatory Affairs Manager (注册事务经理)招聘

Regulatory Affairs Manager (注册事务经理)

百特(中国)投资有限公司 2016-12-06发布 2017-08-01截止
  • 学历要求: 本科
  • 英语要求: 熟练
  • 年龄要求: 不限
  • 专业要求: 药学
  • 工作年限: 十年以上
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 上海市徐汇区
  • 职称要求: 不限
  • 招聘人数: 2人

职位描述

Entity: Baxter (China) Investment Co., Ltd
Division:Regulatory Affairs
Report to:Asso. Regulatory Affairs Director
Subordinates:1-2
Location:Beijing


Job Description

The RA Manager Position will report to the Associate RA director, based in Beijing and provides regulatory support on import nutrition or anesthesia products』 maintenance and introduction to China markets.

Responsibilities:

Being A RA Manager, the professional in this position will fulfill regulatory responsibilities including but not limited to the following:

1.Establish a thorough submission plan with strategic thinking for each assignment within the timeline agreed by stakeholders;

2.Obtain timely approval for new drugs and all other necessary approvals for the existing products maintenance.

3.Ensure regulatory/legal compliance of regulatory activities.

4.Liaising with the relevant governmental bodies and regulatory authorities

5.SFDA, CDE, NIFDC

Qualifications:

1.Bachelor degree or above, major in pharmaceutical or related major;

2.At least 7 years of experience in pharmaceutical industry;

3.Excellent knowledge and competency in Drug registration and relevant technical guidelines.

4.Good relationship with CFDA and the relevant affiliates.

5.Good communication skill, creative thinking, with teamwork spirit; Result and detailed oriented and able to work under pressure to meet tight timelines

6.Good written and spoken English + Mandarin

Good Computer skill.
该单位 HR 近两周的应聘简历处理率: 20%

联系人: Yu Hang

地    址:长乐路989号世纪商贸广场12楼

百特于上世纪80年代进入中国,是最早进入中国医疗市场的大型跨国公司之一。我们的目标始终是让中国患者享有与美国患者相同的医疗产品和服务。秉承着我们的使命和诺言,百特在药物输注、肾科、生物科技、麻醉、营养等领域,将国际最先进的多样化的医疗产品和服务引进中国,旨在提高中国的高质量医疗,为中国患者的生命和生活质量作出有意义的贡献。例如,百特是第一家将全密闭输液系统引入中国医疗市场的公司。

百特在中国持续投入以满足中国日益增长的对优质医药产品的需求。目前我们在上海、苏州、广州和天 ...详情

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