长沙招聘

职位概要：从事进口和国产药品注册工作。

职位描述：

• Acts as a Regulatory representative on simple projects, including provide regulatory expertise input for project design, review documents, technical writing, internal and external communication.
• Manage routine tasks in Regulatory Affairs, including preparing, collecting, reviewing, translating regulatory documentation in area of expertise to support clinical trial and marketing authorization activities, completing regulatory submission and follow up progression, coordinating product testing and get testing report, organizing meeting with authorities.
• Establish and maintain good work relationship with customers and authorities.
• Understands the Scope of Work, deliverables and management of budget and manages workload for simple projects.
• Support BD team on simple opportunities. May present to clients on regulatory strategy and processes by phone or in person, may not only for service bid defense meetings.
• May review the budget and proposal from Regulatory perspective for new opportunity.
• May act as author for regulatory SOPs, as assigned.
• May coach and give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• May prepare and deliver regulatory training to employees from other functions.
• Performs other tasks or assignments, as delegated by Line Manager.

任职资格：

• 药学及相关专业学士学位；
• 从事药品注册工作两年以上，具有生物制品注册经验者优先；
• 熟练药品注册申报资料的编写；
• 掌握中国的药品注册法规和技术指导原则；
• 具有较强的药品注册分析调研能力；
• 具有较强的药学专业英语读写能力，能进行基本的英语口语交流；

    昆拓信诚医药研发（北京）有限公司是艾昆纬公司投资全资子公司，为美资CRO公司，依托艾昆纬公司全球高标准的质量管理系统和资源，昆拓形成了涵盖所有运营部门的完备标准操作流程（SOP）系统以及质量控制体系。
    昆拓秉承诚信、责任、合作、创新的公司文化，致力于成为中国本土临床研究服务的领跑者，以艾昆纬为依托，用心提供高品质的专业化服务。昆拓具有开放、友好的公司文化氛围，制定了严格的人才培养机制，为员工提供了良好的培训以及职业发展平台。
    人员一经录用，公司将提供富有竞争力的薪酬水平。除去国家规定的五险一金外，公司还给员工提供商业医疗保险和商务旅行保险、年度体检、重大疾病保险及人身意外保障等。