药政注册经理 北京

月薪： 15-30万/年

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 02-02 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 员工旅游
  • 餐饮补贴
  • 年终奖金
  • 交通补贴
  • 通讯补贴
  • 绩效奖金
  • 定期体检

职位描述

Major AccountabilitiesReview, compile, and submit IND, CTA, BLA applications, supplements and amendments; Provide regulatory inputs for new project development strategy discussion;Accountable to supervise the direct reports on the implementation of the project regulatory strategy by projects planning and tracking, and project executions;Accountable for achieving the target timeline of submission and approval; Accountable for the communication with Health Authorities (HAs) to properly address the concerns on projects; and the coordination of related HA meetings; Maintain a good relationship with HAs; Communicate with internal cross functional team on the related regulatory issues on the responsible projects;Accountable to provide regulatory support to other functional team; Accountable for ensuring regulatory compliance for the responsible project-related activities, like, maintenance of CTA-related submissions, and give input to relative WIs or SOPs updates;Monitor regulatory changes and report to department head timely; Provide/Assist department head to coach the junior levels; Other appointed tasks. Job Profile(Education & Experience) Education: Bachelor or above with Pharmaceutical/Medical/Science backgroundLanguages: Fluency in English and Chinese (oral and written)Experience: At least 8 years of life science industry experience post bachelor’s degree, with at least 5 years of demonstrated accomplishment in RA field; Or at least 5 years life science industry experience post Master’s degree; Or at least 2 years life science industry experience post Doctor’s degree;The experience in filing and obtaining approval for local or global trial IND/CTA independently;Skills of cross functional communications within the company; Experience in HAs interactions;Experience with SOPs and WI updates; Experience in biologics such as mAb product submission is a plus; Experience with electronic submission is a plus; Experience with CRO management is a plus;The experience in filing and obtaining NDA/BLA approval is a plus. 职能类别： 药品注册 生物工程/生物制药

联系方式

朝阳北路237号复星国际中心30层

公司信息

2009年12月8日，上海复星医药新药研究有限公司与美国汉霖生物技术公司正式签约合资组建上海复宏汉霖生物技术公司，致力于单克隆抗体药物的研发与产业化。公司位于上海市漕河泾新兴技术开发区，注册资本3000万美元。 复宏汉霖主要致力于应用前沿技术进行单克隆抗体药物的开发及商业化，造福更多病患。 目前公司正在开发的产品主要覆盖肿瘤、自身免疫性疾病等领域。公司以全球联动整合创新为产品开发的理念，在中国上海、美国加州和台北均设有研发实验室，配备了单抗药物前期研发所需的符合国际化标准的各项仪器设备，其中上海实验室总面积约3,000 平方米，目前在建中的实验室面积约10,000平方米。现已完成单克隆抗体药物开发平台的建设。另外，复宏汉霖率先向国内引进了先进的一次性生产技术，进行单抗产品GMP生产。借助该项优势技术，复宏汉霖现已实现5年5个产品、5项适应症IND申报的高效研发，位于同行业领先地位。展望未来，复宏汉霖人将始终以“开发优质抗体药物，造福全球病患”为使命，不断探索创新，努力耕耘，积极打造深得信赖，领先中国进而影响全球的生物制药企业。 复宏汉霖矢志成为国内领先、国际一流的生物制药公司。而人才是公司成功的最重要的根基与动力。 期待您的加盟！ 官网：http://www.henlius.com/

北京相关职位
猎才二维码