Regulatory Affair Manager 北京

月薪： 50-60万/年

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布

职位描述

职位描述： 1.Assist RA Director to propose/develop, implement, review and update registration/regulatory affairs strategy plan, manage and supervise the team to ensure product registration and perform regulatory affair activities under policies and standard operating procedures(SOP), and other applicable laws and regulations.2.Oversee the progress and ensure key projects registration approval. Provide proposal to RA director about strategy and action plan of these key projects and implement accordingly. Timely communication with other functions about the projects progress.3.Preliminary review and approve part of registration dossier and other regulatory documents (e.g., local physician circular, packaging components, application letter or appeal letter) to ensure the content is correct.4.Manage overall progress of key projects through project meetings. Coordinate internal departments in product registration process.5.Communicate with regulatory agencies/institutes (e.g., SFDA, CDE, NICPBP, Coast Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, sample testing6.Provide guidance and support to Registration Staff in problem solving and making recommendation on common technical or registration procedure issues7.Participate in regulatory affairs activities assigned8.Cross Functional-Provide input to the new product launch activity if necessary;-Provide input from regulatory point of view to ensure market supply import complying with local regulation.职位要求：1.Bachelor Degree in any life science discipline or the equivalent2.8 years’ experience in pharmaceutical industry3.Good knowledge of relevant laws, regulations and guidelines4.Good command of both written and spoken English and Chinese/Mandarin5.Self-initiated individual with good communication and interpersonal skills6.Social Network efficiency7.Project management efficiency 职能类别： 生物工程/生物制药

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公司信息

广州澳佛莱人力资源服务有限公司（Synergy Consulting）是一家致力于全方位人力资源和管理咨询培训服务的专业机构。经过多年的努力和探索，我们不断地进步和成长。今天，我们拥有多样化的产品和优质的服务，我们拥有值得骄傲的团队和客户。 2010年 澳佛莱在广州成立 2011年 澳佛莱组建猎头部，为综合业务集团公司、制造业、物业地产、化工、医药、国际采购、零售、IT、电子等行业提供中高级人才访寻服务 2013年 澳佛莱上海办事处成立，为客户提供专业中高级人才访寻服务

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