Associate RA Manager
武田(中国)国际贸易有限公司
- 公司规模:1000-5000人
- 公司性质:外资(非欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-04-01
- 工作地点:北京-朝阳区
- 招聘人数:若干人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:30-40万/年
- 职位类别:生物工程/生物制药 法务经理
职位描述
PURPOSE In accordance with the company’s product launch strategy, lead and coordinate the process of drug registration and ensure the compliance of technical documentation and process to ensure the success of drug registration. Complete related registration work of listed product during the registration cycle to ensure continuous effectiveness of the Import Drug License. RESPONSIBILITIES 1. In accordance with the company’s product launch strategy and department’s work plan, take full responsibility of the product registration and application for approval and develop the plan by stage. Contribute to decision making on drug registration leading to minimal registration timeline. 2. Solve the problems occurred during drug registration in uncertainty Chinese pharmaceutical environment to achieve drug registration approvals in timely and cost effective way. 3. Summarize product registration related materials with coordination among head office, factory, Sales & Marketing. Provide corresponding support for the sales in China market. 4. In accordance with the plan of product registration and application for approval, manage the necessary materials and information during the process and track and summarize the progress. 5. Be responsible for submission of complete and qualified product application data to drug regulatory authorities, coordination of raw data review and on-site assessment. 6. Manage and archive examination and registration materials and other relevant documents. 7. Provide necessary support to the preparation and implementation of clinical trial. 8. Establish influential relationships with key regulatory authority individuals and KOLs in relevant fields, such as SFDA, CDE, NIFDC, PIDC and etc. Monitor regulatory environment and collect important information such as regulations, guidelines, competitive products and etc. 9. Establish and maintain internal/external channels of communication. 10. Ensure regulatory activity is in compliance with authority and Takeda policy. 11. Coordinate with the establishment of internal SOP and system.
公司介绍
在创立230多年后的今天,武田在全球拥有约30,000名员工,业务和运营覆盖超过70个国家和地区。每年,武田将全球总营业额的大约20%投入研发。超过700个产品覆盖六大关键治疗领域:心血管与代谢、肿瘤、呼吸与免疫、中枢神经系统、普药、疫苗,销往全球90多个国家和地区。
武田的国际品牌标志代表一座桥梁,象征着武田连接起***突破和满足病患需求的诊疗方案,也象征着武田和医疗保健服务密切相关的病患、医生等社会成员紧密联系。“武田主义”是武田的企业理念之本,是在其所有运营活动中坚守的核心价值。武田承诺,在任何时候,尤其是面对困难与挑战时,公司都奉行以公平、正直和坚毅为基础的“诚信”准则。
武田为成为一家真正的全球化制药企业而不断努力,希望能提供满足各种各样医疗需求的解决方案,为全世界人们的生命健康和美好未来做贡献。
联系方式
- Email:SMB.Recruitment@takeda.com
- 公司地址:静安区会德丰广场 (邮编:200000)