注册专员/Regulatory Specialist社

面议

市辖区本科及以上2年及以上

发布时间：2023-09-06

职位描述

You will be responsible for filling the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP manner
Main Tasks & Responsibilities
Prepare the registration dossier to submit to NMPA and obtain the approval to meet the registration plan.Make sure the accuracy and truthfulness of the registration dossiers and maintain all the submission and approved dossiers in related IT systems, share points, V drive, and notify all the stakeholders per company SOP requirements.Complete the related payment procedure in systems on time, place order for FOC for the QC testing.Working together with RAM, active join the discussion and verification of in the national standard or panel verification or national /industrial standard discussion and verification.Working together with global team, to draft the PTR and complete the type testing on time if needed.As a member of RD, provide active and strong regulatory supports to internal dep. as needed.Initiatively deal with daily works. Keep records. Have clear filing and maintain of all documents, update in RA related IT systems, share points, V drive on time.Other projects or tasks assigned by line manager.Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.Basic Requirements of the Job
You should have not less than 2 years’ experience in medical regulatory affairs, focusing on testing center and clinical trial, and understand IVD products’ standard like industry and national standards (YY and GB)You should have high enthusiasm and devotion, work hard and earnestYou should be willing to work under pressure, self-starting and self-inspiringYou should be honest and open, excellent interpersonal communication skill, ability of social activity and collaborationYou should be innovating with good independent working abilityYou should have energetic team spir*******************

其他要求

招聘人数：1人
职能类别：医疗器械生产

公司介绍

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗**、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与**、医疗机构以及非**组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏中国网站 ****************