生物制药高级注册法规经理 上海

月薪： 1-1.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Sr. Manager/Assistant Director, Regulatory Affairs CMCWuXi Biologics (Shanghai/Wuxi)MAJOR RESPONSIBILITIES？Provide regulatory CMC guidance to the project teams to ensure development activities are compliant with relevant guidelines and governmental regulations？Support the preparation of CMC regulatory submissions namely INDs/BLAs applications including scientific and technical review for accuracy, soundness and regulatory appropriateness？Ensure timely preparation and management of all necessary documentation for regulatory submissions？Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines？The candidate is expected to maintain up-to-date knowledge and expertise of relevant ICH guidelines, CFDA, FDA, and EMA regulations？Responsible for establishing and maintaining internal filing template and ensure submission quality and consistency？Represents WuXi Biologics in interactions with Regulatory Agencies and clients’ RA CMC representatives.QUALIFICATIONS REQUIREMENTS？The candidate must demonstrate solid working knowledge of biologics development processes.？Thorough understanding of FDA and EMA regulatory requirements and GMP regulation is required？The candidate must be detail oriented with strong project management, problem-solving, negotiating, interpersonal, and communication skills (both written and oral).？The candidate must have expertise in Chinese FDA regulations and experience interacting with CFDA. The candidate must be fluent in Chinese both written and oral？Minimum BS degree in one of the relevant life sciences is desirable. Advanced degree and RAC certification are pluses.？BS degree with 8-10 years experience？MS degree with 5-8 years experience？PhD degree with 3-5 years experience 职能类别： 生物工程/生物制药 关键字： 生物制药 药品 注册 法规

联系方式

上海市外高桥保税区富特中路288号

公司信息

药明生物（WuXi Biologics）是香港上市公司（代码：2269），我们是全球领先的开放式、一体化生物制药能力和技术平台，旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司，并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。目前，公司规模达到2300多人，有200多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产团队。 更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/

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