生物医疗注册经理

Job Functions工作职责
Job functions include, but are not limited to the following:
工作职责包括但不限于：
61 Serve as Subject Matter Expert in NMPA/FDA/EMA regulations, registration processes, document review principles, and technical requirements.
在NMPA/FDA/EMA法规事务，申报注册程序，文件审核原则以及技术要求等方面作为专家（SME）参与其中。
61 Contribute to company systems development, which may include regulatory related SOPs, management systems, and working procedures, to improve team operational efficiency.
帮助完善公司体系，建立和加强法规相关SOPs，管理体系，工作流程等，以确保整个团队运转高效。
61 Perform and manage day-to-day product registration affairs and ensure the registration tasks assigned are completed on time and in compliance with regulations, guidelines, and internal processes.
执行和管理日常注册工作，确保依照法规指南要求和公司内部流程及时完成申报注册任务。
61 Write, compile, and review registration dossiers to ensure the completeness and accuracy;
撰写，汇总并审阅申报注册资料，确保申报资料的完整性和准确性;
61 Establish and continuously improve template documents used by development, manufacturing, and quality departments to streamline writing and compiling CMC dossiers;
建立并持续改进用于研发，生产和质量部门的文件模板以简化写作流程并撰写CMC文档；
61 Closely follow regulation changes and analyze/predict their impact on company registration strategies. Make recommendations to Company Management, Project- and CMC-teams, and Clients where required; and
紧密跟进法规的变化，并分析/预测法规变化对公司申报注册策略的影响, 并根据需要为公司管理层，项目管理团队和CMC团队以及客户提供建议;
61 Interpret Regulations and Regulatory Guidance of GMP and GLP in design of facilities, creating processes, and selecting materials in setting up the business, negotiating Quality Agreements with Clients, and preparation of on-site inspection conducted by Regulatory Authorities.
在厂房设计，流程制定和为商业需求筛选材料过程中对GMP和GLP相关法规要求进行解读，与客户进行质量协议的讨论，并为监管机构的现场核查进行准备。
61 Maintain/archive regulatory documentations。
整理归档申报资料。
61 Primary liaison with Regulatory Authorities and other related agencies。
与监管或其他机构的主要联络人。
Site Safety and Environmental compliance 现场安全和环境合规
61 Promote a culture of safe workplace through personal actions;
以身作则推动建立安全的工作环境；
61 Adhere to the Company’s safety and environmental protection procedures.
遵守公司的安全环保程序。
Quality Assurance 质量保证
61 Comply with the Company Quality Management System.
遵守公司制定的质量管理体系。
61 Contribute to writing Quality Management System documentation for Regulatory Affairs processes and procedures.
需要参与撰写项目管理流程和步骤相关的质量管理体系文件。
General 常规要求
61 Maintain effective, collaborative, and frequent interactions with clients and other departments to ensure harmonization in scientific and technical approaches;
与客户和其他部门保持有效、协作和频繁的沟通，以确保科学和技术方法的协调；
61 Select and recommend products (e.g. software, industry publications) and services (e.g. technical writers) that enhance efficient operation of the Regulatory Affairs function and completion of CMC section for client projects;
需要对相应的产品（如软件，行业出版物）和服务（如技术文档撰写）进行筛选并提出建议，用以促进申报注册版块的高效运作并为客户项目完成其CMC部分工作
61 Comply with Company Policies and Procedures and contribute positively to Company Morale;
遵守公司政策和程序，积极提升公司士气；
61 Other reasonably duties as requested by Company Senior Management from time to time.
完成领导提出的其他任务
Qualifications任职资格
61 Bachelor’s degree or above in Biochemistry, Biochemical Engineering, Bioprocessing or related field.
生物化学、生物化工、生物工艺过程或者其他相关专业学士学位及以上。
61 At least 5 years regulatory affairs experience within in pharmaceutical industry.
超过5年以上的药品申报注册经验。
Essential Experience必要经验
61 Expert in NMPA, FDA, EMA and ICH related regulations, guidelines and requirements;
熟悉NMPA, FDA和ICH相关的注册法规，指南和技术要求；
61 Good written and oral communication skills;
良好的书面和口头表达能力；
61 Sound knowledge of biologics CMC development;
在生物药的CMC开发方面具备全面的知识；
61 Previous experience in dual IND filing in China and USA or Europe;
具备在中国，美国或者欧洲递交双语IND申报的经验；
61 Advanced computer system skills for Microsoft Office suite (Word, Excel, PowerPoint, Project, Outlook).
熟练使用Microsoft Office办公软件（Word、Excel、Powerpoint、Project、Outlook）。
Preferred Experience优先考虑
61 Advanced postgraduate qualification (MS or PhD) related to biopharmaceutical development;
具备生物医药研发相关的高级学位（硕士或博士）；
61 Sound knowledge of Good Manufacturing Practices including NMPA, ICH, and US-FDA guidelines with focus on biologic products;
在GMP方面具备全面的知识，包括NMPA，ICH和US-FDA发布的针对生物制品的相关指导原则；
61 Hands-on experience on China BLA filing or FDA IND filing;
具备中国BLA申报经验或者美国IND申报经验；
61 Hands-on experience of on-site inspection conducted by NMPA, EU or FDA.
具备中国，欧盟或美国现场核查经验。
The preceding statements are intended to describe the general nature and level of work being performed by people assigned to this role. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
前面的陈述旨在描述该岗位人员从事工作所需的一般要求和水平。它们并不是该岗位人员所需的所有责任、职责和技能的详尽清单。