Regulatory Affairs Specialist(001804) (职位编号：TASLY001804) 天津

月薪： 6-8千/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 出国机会
  • 专业培训
  • 定期体检
  • 免费班车

职位描述

职位描述： 岗位职责:Job Objective:To develop and implement the regulatory strategy and be responsible for preparing submitting and supervising all relevant documents for IND/ NDA application to regulatory authorities. This will include interactions with regulatory agencies, authorities and other key players in the regulatory environment.Job Responsibility: 1.Define local regulatory development strategy for the JV products.2.Develop local regulatory submission strategies for the JV products.3.Follow up the policies and guidelines issued by Chinese drug regulatory authorities.4.Close cooperation with project leaders to define the best project regulatory submission strategy.5.Conduct regulatory reviews of technical summaries, study reports, and administrative documents for regulatory filings to support clinical trials in collaboration with functional experts.6.Advise on regulatory aspects of protocols and implementation of clinical trials.7.Ensure timely submission and appropriate follow-up.8.Interact directly with regulatory agencies/competent authorities and/or other regulatory or functional experts and represent the company with health authorities.The position is based in China and requires domestic and international travels. 任职资格:Job Requirements:1.BS or above degree in a relevant field with at least 5-year regulatory affairs experience in pharmaceutical and/or biotechnology industry in China.2.Experience and understanding of Drug development as well as understanding of biology relevant to therapeutic area.3.The candidate must be a team player, self-starter, strategic thinker, persistent, tactful, and persuasive.4.Excellent verbal and written communication skills : accustomed to communication with authorities and ability to convince through knowledge and interpersonal skills.5.Oral and written English is essential.Preferred: 1.New drug development experience.2.To have cross-cultural sensibilities in a complex business environment. 职能类别： 药品注册 知识产权/专利/商标

联系方式

北辰区普济河东道2号 天士力现代中药城

公司信息

天士力医药集团股份有限公司创建于1994年，公司成立以来，始终秉承“创造健康，人人共享”的企业愿景，推动中医药与现代医学融合发展，以提高人类生活和生命质量为使命，致力于打造中药现代化、国际化***，以成为全球现代中药创新的领导者、现代中药科学标准的制定者为目标，实现现代中药为核心，协同生物药和化学药为两翼的国际化产业格局。 公司业务涵盖医药领域的科研、种植、提取、制剂、营销全产业链，为国家认定的高新技术企业。公司产品以现代中药为核心，协同生物药和化学药为两翼的发展新模式，构建了现代生物医药产业集群。

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