Regulatory Affairs Manager or above 上海

月薪： 5元/小时

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-15 发布

职位描述

职位描述： About PositionDepartment:Regulatory AffairsEmployment Status:Full time employeeWorking Location:Shanghai, ChinaOverview?Regulatory lead for CStone products, including IND/NDA submission, CDE/NIFDC follow-up, communication and etc.;?Be accountable for CDE pre-meetings in preparation and implementation;?Compliance with applicable policies, procedures and other regulations.Responsibilities?Regulatory inputs for IND/NDA strategy making;?Be accountable for IND/NDA preparation, submission and PFDA review;?Follow up with review/approval process and coordinate with internal function team to response promptly;?Be accountable for the implementation of registration planning and tracking;?Be accountable on achieving the target timeline of submission and approval;?Provide regulatory support to line functions;?Contribute to optimize RA operational procedures whenever is needed;?Ensure regulatory compliance for responsible documents and archiving;?Closely monitor regulatory development and report to department head timelyQualification?Bachelor or higher degree in life science areas preferably in pharmacy, biology or medical science;?At least 5 years of RA working experience on IND/NDA submissions;?Familiar with registration regulations and tech guidance; Proficiency in the organization of the registration package and writing of summaries;?Familiar with the registration process and requirements;?Outstanding communication skills; Capable of working independently and proactively with high team spirit and good interpersonal relationship;?Good skill in English speaking and writing. 职能类别： 药品注册

联系方式

张衡路1000弄

公司信息

CStone Pharmaceuticals is an innovative, research-based, biopharmaceutical company committed to the development of a new generation of therapeutic drugs. Based in both Shanghai and Suzhou, the company's leadership team consists of seasoned executives from top pharmaceutical MNCs. In July 2016, CStone announced the completion of its Series A financing, raising a total of US$150 million (about 975 million RMB). Three prestigious investment companies in the industry, Oriza Seed Venture Capital (Oriza Seed), Boyu Capital, and WuXi Healthcare Ventures (WXHV), jointly invested in the round. With an overarching commitment to meeting the most pressing needs of Chinese patients, the company's pipeline covers five therapeutic areas, including oncology, cardiovascular diseases, rheumatoid arthritis, hematology and autoimmune diseases. With immuno-oncology as CStone's core therapeutic focus, the company strives to lead Chinese research to the global market through its world class R&D team, its innovative portfolio, and an open innovation strategy.基石药业是一家创新的研发驱动型生物制药公司，致力于开发新一代的治疗性药物，创立于中国上海和苏州两地，公司的领导团队由来自国际顶尖药企的管理层成员组成。 2016年7月宣布完成A轮融资，共募集到1.5亿美元（约9.75亿人民币）资金，由三家颇具声望的投资公司参与，分别是元禾原点创业投资管理有限公司、博裕资本及毓承资本。目前，基石药业拥有肿瘤、心血管、风湿性关节炎、血液病及自身免疫病等五个治疗领域的产品线，旨在满足中国病患重大迫切的临床需求。在广受瞩目的肿瘤治疗领域，基石药业以其出色的肿瘤免疫药物为核心，凭借其世界级的研发团队，最前沿的药物研发项目，以及开放式创新的策略有望引领国内新药研发行业走向全球。

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企业入驻日期： 2017-11-15

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