法规事务专员 牡丹江

月薪： 3-8千/月

该公司所有职位
  • 2年经验
  • 本科
  • 招2人
  • 01-02 发布
  • 五险一金
  • 免费班车
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 定期体检
  • 免费公寓

职位描述

1. Coordinate and document internal regulatory processes, license renewals, or registrations and compile and prepare materials for submission to national/international regulatory agencies.协调并记录内部管理流程，更换执照，或进行注册，编写并准备国内/国际监管机构的提交材料。2. Compile and maintain regulatory documentation databases or systems.编制并维护监管文件数据库或体系。3. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.与法规机构沟通提交前的策略，潜在的监管途径，合规检测要求，或审核后的阐明及后续提交。4.Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.解释监管规则或规则变化并确保他们按照公司策略及规程进行沟通。5. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.对将整合到监管部门的提交文件内的数据及报告进行技术审核以保证展示的科学严谨性，准确性及明确性。6. Conduct coordination, preparation and submission of INDs, NDAs, and MAAs in eCTD and paper formats.协调，准备并提交电子及纸质版INDs，NDAs及MAAs。7.Hands-on Publishing and Verification of regulatory dossier submissions such as IND safety reports, Annual Reports, Periodic Safety Reports, Supplements, and Amendments.亲自出版并确认法规提交文件例如IND安全报告，年度报告，季度安全报告，附录及修订案。8. Maintain all regulatory and health authority submissions archiving.维护所有监管及卫生监督部门的归档文件。9. Verification of regulatory documents in electronic document management system.确认规范性文件在电子文件管理体系内。10. Maintain a two way communication with European QP and the pharmacovigilance process.维护与欧洲质量受权人的双向沟通及药物安全监视流程。11. Complete other jobs assigned by the Quality Operation Director.完成质量运营总监分配的其它工作 职能类别： 药品注册

联系方式

海林市海林经济开发区东旭路7号

公司信息

公司总部位于美国加利福尼亚州圣地亚哥，生产工厂位于中国东北部风景优美的黑龙江省。基纳瑞克斯提供包括技术转移、工艺开发、放大实验、设备/工艺验证，配液、灌装、冻干、检验、完整性检测、贴标签及装盒等的整套服务，符合美国食药监局、欧洲药品管理局、中国食药监局及日本法规机构的要求。With our corporate headquarters located in San Diego, California, USA and our manufacturing facility located in the scenic Heilongjiang Province in the north eastern part of China OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulatory

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