注册经理/高级经理

面议

北京市

刷新时间：2022-10-21

职位描述

  工作职责

1. Participate in the company’s product development strategy and plan (TPP, CDP), contribution from RA
perspective.
参与公司的产品开发战略和计划（TPP、CDP）制定，提供注册支持。
2. Proactively partner with stakeholders to lead development of innovative regulatory strategies for
responsible products.
积极与相关干系人合作，负责产品的注册策略的制定。
3. Pay close attention to regulatory environment, provide timely assessment of the impact of new/changing
regulations on the products. Provide consultation, interpretation, and advice to relevant departments with
regulatory guidelines/requirements.
密切关注监管环境，及时评估新/变更法规对负责产品的影响。根据监管指南要求向相关部门提供咨
询、解释和建议
4. Conduct Intelligence of competitors/new drug registration pathway, analysis industry trends, and provide
direction and strategy support for product registration
对同类产品/新药注册路径、行业趋势进行情报收集及分析，为产品注册提供方向和战略支持
5. Be accountable for regulatory strategy implementation, including HA meetings, IND、NDA, QC testing etc.
负责注册策略的执行，包括监管会议、IND、NDA、注册检验等。
6. Act as project manager to lead cross functional team to prepare the submission dossiers, Including
formulate submission strategies, complete the preparation, writing and proofreading of product related
module data (including but not limited to CMC, pharmacology and toxicology, clinical trials and other
module data), follow up the registration progress and inspection, reply to review opinions, and timely
coordinate the problems in the registration process, to ensure meet or accelerate the timeline and with
high quality.
领导跨职能团队准备递交资料，包括制定递交策略，完成产品相关模块资料的准备、撰写、校对（包
括但不限于 CMC, 药理毒理、临床试验等模块资料）, 跟进注册及核查进度，回复审评意见，及时协调
注册过程中出现的问题，以确保在规定时间内高质量完成递交任务。
7. Ensures the solutions to regulatory issues are identified and mitigation plans are put in place, provide
regulatory guidance to cross functional team to resolve the problems occurred during registration to
achieve registration approval in a timely and effective manner.
识别注册风险及问题并制定缓解方案，为跨职能团队提供法规指导，以有效解决注册过程中出现的问
题。
8. Cooperate and coordinate with the cross-functional team to complete various inspections and audits of
Healthy authorities during the registration.
与跨职能团队合作和协调，完成注册期间的现场核查等各项核查任务
9. Establish and maintain good relationships with the authorities and experts to ensure effective
communication. Plan and organize the communication with CDE at key time nodes, response for timely
submission of registration application materials and timely response to healthy authorities.
与监管部门和专家建立并保持良好关系，以确保有效沟通。计划和组织与 CDE 在关键时间节点的沟
通，及时提交注册申请材料，并及时回复监管部门的问题。
10. Work on RA related SOPs draft and update. Be responsible for regulatory submission dossiers archiving and
electronic documents management.
制定和更新与 RA 相关的 SOP，负责递交资料归档和电子文件管理

工作要求

• Bachelor’s degree or above in CMC, pharmacology, pre-clinical or clinical
药学、药理毒理、药代或临床相关本科以上学历
• More than 5 years of working experience in the field of new drug registration, with biological product
registration projects and /or clinical project management experience in innovative drugs
5 年以上新药注册工作经验，有申报生物制品注册项目和（或）创新药临床项目管理经验
• Be familiar with biologics research, production, and other related knowledge, be familiar with the technical
guidelines related to biological CMC and be able to provide support and guidance from RA perspective to
CMC development & control.
• 熟悉生物制品药学研发、生产等相关知识，熟悉生物制品药学相关技术指导原则，能从注册角度对公
司项目的药学研发和生产控制公司提供支持和指导
• Have strong organization, planning and coordination skills, good communication skills, sense of
responsibility, continuously upgrade professional knowledge, improve work ability, good professionalism,
and professional ethics
具有较强的组织、计划、协调能力、善于沟通、有责任心，能持续更新专业知识，提高工作能力，良
好的敬业精神和职业道德操守
• Proficient in the application of office software, with strong independent learning ability and information
collection, analysis, and summary ability.
熟练应用 OFFICE 办公软件，具备较强的自主学习能力和信息采集、分析、汇总能力。

其他要求

招聘人数：1人
职能类别：注册部经理/主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。