Regulatory Intelligence 北京

月薪： 0.6-1.2万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 绩效奖金
  • 年终奖金
  • 定期体检

职位描述

职位描述： Monitoring and search of CFDA relevant laws, guidelines and other pieces of regulatory information (draft/in force) from Health Authority webpages and public databases, public conferences, workshops and associations activitiesIssue monthly China regulatory report (and alerts when necessary)Coordinate to collect NVS internal comments on draft legislation/guidance and organize internal position about draft legislation/guidance in order to influence HA via interactions with Authorities and association, such as RDPAC and PhRMAMonitor CDE backlog solving progress and key projects moving speed in CDE to support DRA planning and strategy adjustedUtilize external information from CDE website or provided by vendors about regulatory information (such as GBI, 丁香园), to support DRA team to setup internal data base for well planning and communicationsCoordinate other regulatory intelligence work assigned by GDD China RA officeCoordinate internal trainings to DRA colleagues about emerging regulatory requirements by or cross functionally and via written communication, such as newsletters, information e-mails etc.Setup local DRA regulation data base in DRA SharePoint任职要求：BS degree or above on pharmaceutical, medical or Bio scienceFluency in English as a business language, good written English will be a plusHandled registration project and familiar with CFDA drug registration regulation and processMonitoring and search of relevant laws, guidelines and other pieces of regulatory information (draft/in force) from Health Authority webpages and public databases, public conferencesHaving people net with RA of industryGood at communication, open mind and team work spirt 职能类别： 药品注册

联系方式

北京市朝阳区建国路91号金地中心B座917

公司信息

RPS Inc. is a next generation global CRO, headquartered in the United States with the operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions. RPS provides comprehensive global Phase 1-4 clinical development solutions to the pharmaceutical, biotechnology and medical device industries. By combining an experienced clinical research operations infrastructure with the industry’s largest resourcing engines, RPS is uniquely positioned to offer our Clients both integrated and full service global outsourcing solutions. These solutions are powered by highly experienced and seasoned study teams providing innovative, cost-effective and high quality services. RPS Asia Pacific Headquarters is located in Beijing, China and we have operations in 11 Countries in Asia Pacific region. With the rapid organic expansion of RPS in China & Asia Pacific, we are continuously looking for the experienced industry talents to join us. Our specialized staff of consultants is eager to discuss your career plans. Tell us about yourself experience, so the appropriate consultant can contact you. RPS is sensitive to your daily responsibilities. Tell us EXACTLY how to contact you and we will. For your convenience, you can also submit your resume. We look forward to discussing the opportunities and benefits of employment with RPS! For more information, please visit our website www.rpsweb.com.

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