RA Manager - CMC 上海

月薪： 1.5-2万/月

该公司所有职位
  • 无工作经验
  • 招若干人
  • 12-19 发布
  • 五险一金
  • 免费班车
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 出国机会
  • 绩效奖金
  • 年终奖金
  • 定期体检

职位描述

Job functions including but not limited to,1. Drafting and editing the registration dossiers based on the China specific regulation requirements, especially CMC part etc.;2. Executing the submissions/filing based on the registration plan, and complete the registration affairs tasks for new products application and regulatory compliance for post-marketing products according to the local regulations and registration plan/strategy.3. Developing strong partnership with other departments especially with R&D/GMP and commercial development, Juno US team etc.4. Developing and maintaining the collaborative partnership with key stakeholders, e.g. HA officials, reviewers and experts etc.5. Ensures registration projects completed timely.6. Complete the other tasks, projects the supervisor assigns7. Development and implementation of standard operating procedures8. Keeps high alerts on regulatory intelligence.9.Others the line manager assigned.Qualification:1. Integrity and high discipline, maturity, high responsibility; passion for excellence; good communication skill and teamwork spirit;.2. Degree in Scientific, Life Science/Biochemistry/Pharmacy3. At least 7 years’ working experience in regulatory affairs, CMC dossiers drafting experience is required 4. Minimum 4 years Biologics experience required, Immunotherapy is preferred 5. Ability to provide input, guidance and recommendations by quick learning in the new files and knowledge from different sources 6. Highly self-motivated; initiative7. Strong interpersonal and communication skills8. Good spoken and written skill in both Chinese and English 职能类别： 政府事务管理 关键字： RA Manager -CMC

联系方式

上海市外高桥德林路90号

公司信息

全球肿瘤细胞免疫疗法的领军企业Juno Therapeutics(NASDAQ：JUNO)与药明康德宣布在中国建立上海药明巨诺生物科技有限公司(JW Biotechnology Co. Ltd），双方将结合Juno世界领先的嵌合抗原受体技术(CAR-T)和T细胞受体(TCR)技术，以及药明康德的研发生产平台及公司丰富的中国本地市场经验，联合打造中国领先的细胞疗法公司，为血液肿瘤和实体肿瘤病人开发创新的细胞免疫疗法。

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