Senior RA Manager/ Associate Director 上海

月薪： 30-40万/年

该公司所有职位
  • 8-9年经验
  • 本科
  • 招1人
  • 11-13 发布

职位描述

职位描述： Responsibilities:Job functions including but not limited to,1.Shaping healthcare environment, especially Oncology Cell Immunotherapy area (CAR-T), e.g. be actively involved in establishment and revision of regulations, guidelines and national standards; provide trainings to HA.2.Based on the company's strategy, establishes registration plan for submissions / estimated & effective approval dates, and complete registration affairs tasks for new products application, including dossiers/package preparation, filing, QC test and following up etc. during the whole registration phase.3.Regulatory compliance/maintenance for post-marketing products according to the local regulations and registration plan/strategy.4.Developing and maintaining the collaborative partnership with key stakeholders, e.g. HA officials, reviewers and experts etc.5.Developing strong partnership with other departments especially with R&D/GMP and commercial development, Juno US team etc.6.Providing effective communication to functional organizations and project team members.7.Development and implementation of standard operating procedures,8.Ensure registration projects completed timely.9.Keep high alerts on regulatory intelligence.10.Other tasks that line manager assignsQualification: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 8 years’ working experience in regulatory affairs4.Minimum 4 years Biologics experience required, Immunotherapy area is preferred5.Ability to provide input, guidance and recommendations by quick learning in the new files and knowledge from different sources6.Ability to establish and maintain good regulatory networking internally and externally7.Capable of identifying key stakeholders in managing an issue8.Highly self-motivated; initiative9.Strong interpersonal and communication skills (writing & verbal) with excellent command of English.10.Strong organizational and negotiation skills; High influencing skills11.Good spoken and written skill in both Chinese and English 职能类别： 药品注册

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。

上海相关职位
猎才二维码