【Sr. Manager, Regulatory Affairs, China招聘】_梯瓦医药信息咨询(上海)有限公司招聘信息-猎聘

陈女士 6天前在线已认证

招聘经理 · 梯瓦医药信息咨询（上海）有限公司

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职位介绍: Major Accountabilities: • Set China regulatory strategies, including regulatory risk assessments, and support for all development compounds (registration) and marketed products (life cycle management) in responsible TAs. • Ensure the registration strategy flawless implemented for application sub and approval of oversea drugs, generics and biosimilar etc. including local clinical trial permits applications, Int’l CTA, BE, import drug license applications. • Prepare and compile regulatory dossiers for submission and ensure submission projects are on track and filed in a timely manner. • Support China operations on relevant legislation, directives and regulations within China including originator, generics, Biosimilar, OTC, etc business in responsible TAs • Work closely with internal partners to ensure compliance with internal process and external regulatory requirements • Support department SOP and operation system, maintain and ensure internal regulatory data can be timely captured. • Monitoring regulatory environment, interpret and share with internal team; maintain industry associations. • Establish & maintain good relationship with HA Qualifications & Requirements: • At least University Degree in life science, medicine, pharmacy or material science. • At least 6 years’ experience in drug registration in China and working experiences of regulatory affairs, experience in MNC pharmaceutical industry is preferred. • Good knowledge in China registration and assessment capability of imported drugs. • Good knowledge of regulatory and healthcare system in China. • Strong English communication skills both written and oral in view of building effective stakeholder relationship • Excellent interpersonal skills, teamwork and collaboration. Experience of People management is preferred. • Understanding of local regulatory environment, key initiatives – specifically regulation change and trends • Innovative and creative, openness to change and ability to think out of box. • Demonstrated project management ability. • Results oriented, entrepreneurial and self-motivating.

其他信息: 语言要求：英语、普通话; 所属部门：注册部

公司简介

梯瓦是一家总部位于以色列的全球性医药公司，在全球拥有 40,000 名员工，在近 60 个国家开展业务。Teva 致力于改善健康状况，并在全球范围内增加获得高质量健康解决方案的机会。我们的员工是我们成功的核心，我们在80多个国家的同事每天为2亿人提供医药服务。我们为患者提供独特多样的产品组合和解决方案，并围绕我们的核心治疗领域建立了一个有前途的管道。我们正在不断开发以患者为中心的解决方案，并通过在研发、营销、业务发展和创新方面的投资，显著增长我们的仿制药和特种药业务。这就是我们如何改善健康，使人们过上更好、更健康的生活。加入我们的成长之旅！

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