[北京]百济神州（北京）生物科技有限公司

职能类别:其他

Responsibilities:
? Supports line manager or regulatory working team to compile CTA, NDA, supplementary dossiers and prepare for HA meetings, if necessary.
? Supports submission, lab testing, inspections, and other regulatory activities related to drug registration process.
? Maintains the product information including clinical trial information, quality control information, any developing changes etc. under compliance with the local HA requirements during developing stage
? Maintains the on-market products’ lifecycle including PSUR filing, CMC variations, renewal filing and any post-market approval commitment, etc.
? Collects information of competitive products and provides related supports to other functions.
? Maintains regulatory tracking system for registration procedure to ensure clear record and archive.
? Assists line manager to complete assignment as requested in a timely manner.
Qualifications:
? Working experience in international company is preferred.
? Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
? Excellent interpersonal communication skills.
? Good command of written and oral English and Mandarin
? Good management of time;
? Fast learning capability.

公司名称:百济神州（北京）生物科技有限公司
公司类型:上市公司
公司介绍:百济神州是一家植根中国的全球性商业化生物制药公司,致力于成为分子靶向药物和肿瘤免疫药物研发领域，以及商业化创新领域的全球领导者。
我们拥有行业领先的自主研发能力和丰富的产品管线。包括10款在研管线药物，其中6款由内部自主开发，3款已进入临床后期。我们是首家在中国和全球范围同步开展注册性临床试验的创新药企之一，目前在5大洲开展临床试验。
我们专注质量，建设符合国际标准的生产设施。我们于2017年在苏州建成可生产商业规模小分子药物和临床规模生物制剂候选药物的生产基地，目前正在广州建设用于生产商业规模大分子单克隆抗体类抗癌药的生物药生产基地。
我们持续打造商业化运营能力。2017年，我们成功过渡为商业化阶段公司，并吸纳行业优秀人才，不断壮大商业运营团队。
我们是首家在纳斯达克和港交所双重一级上市的生物科技公司之一。