天津招聘

The Job:
-To develop and maintain the product portfolio of the company.
-To establishes, implements, and directs the application of policies, procedures, and operating processes in compliance with all appropriate laws, regulations, policies, and conventions
- 公司各类产品的开发和维护
- 根据各种相关法律、规章、政策和协定的规定，确立、执行相关政策、规程和运作程序，并对其运用加以指导

------------------------------

Responsibilities:
To make regulatory strategy, including analysis of products from a regulatory point of view and implementation of procedures required to put them on market
Set up, submission and follow up of files required for pharmaceutical marketing Au-thorization, medical device or cosmetic license
Follow up of product variations (manufacturing site change, Active ingredient or fin-ished product specification change…): adapt the core variation dossier to Chinese regu-lation, submission, achievement and implementation of the variation to packaging com-ponents (leaflet, carton, strip, tube) if needed
Make product license renewal activities
Regulatory monitoring of all promotional operations (consulting, documents, public re-lations, etc.)
Establish and consolidate the relationship with internal and external key stakeholders
Regular communication with global team
Take part in the preparation of internal operating procedures of the operating site, and following company SOP for regulatory documentation archiving
Collect policy intelligence and assist to evaluate the impact of regulatory changes to the company
Drawing up of reports relating to legislation affecting medical devices, etc.
Take part in the preparation of the operating site inspections
制定法规事务战略，具体包括从法规视角进行产品分析，以及执行将产品推向市场所需的相关规程
制定、提交和跟踪获取药品上市许可以及医疗器械或化妆品的相关许可所需的各种文件
及时跟踪产品变更的情况（生产地点的改变、产品有效成分或产成品规格的改变……）：必要的时候，对重点变更内容做出调整，使其与中国的法律规定以及提交、完成和实施的包装材料（说明书、包装纸盒、条状包装、包装管）变更保持一致
及时更新产品相关许可
对所有宣传推广活动实施监管（咨询、文件、公共关系等方面）
建立和巩固与企业内部和外部的重要利益相关方的关系
定期与全球团队开展沟通交流
参与经营现场的内部作业程序的制定，并遵照公司的SOP（标准作业程序）的有关规定，完成法规事务文件的归档处理
收集政策情报，协助评估相关法规变更对公司的影响
编写相关报告，分析说明有关立法对药品和医疗器械等产品所产生的影响
参与经营现场检查的准备工作


---------------------
Qualification requied:

BA degree in Medical or pharmcy or a combination of education and experience providing equivalent knowledge or above
Minimum 5 or above years' experience in Regulatory Affairs
Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with global/local project team personnel.
Demonstrated ability in project management skills in order to plan, conduct and implement regulatory submissions
Skill in determining alternatives that would correct a situation to comply with standards and regulations
Well communication skill both in Chinese and English
医学或药物学学士学位（BA），或兼备同等的或更高的教育背景和实践经验
至少拥有5年或以上的在法规事务领域的工作经验
必须有能力及时做出清晰、简洁的口头和书面报告，并具有与全球/地方项目团队人员进行有效沟通的技巧。
具备项目管理技巧，能够对法规事务材料申报提交工作做出规划、引导和执行
有能力确定应变方案，对相关情况做出调整改变，从而满足相关标准和规章的要求
良好的中、英文表达和交流能力

    好伯咨询（Horbo Talent Solution）始于2007年，是一家服务覆盖大中华地区的专业猎头机构，在上海、香港、澳门设有执行机构，专注于为公司客户提供高级管理及专业人才的猎聘、背景调查等高品质人力资源服务。

    秉承精品猎头、匠心服务理念，基于精细、专业的运作流程，Horbo一直保持很高的人才推荐精准度和推中率，在招聘服务市场享有优良的口碑，是用人企业可依托的业务合作伙伴，是职场精英可信赖的职业顾问，是招聘服务专家，是识人鉴人的“伯乐”。

    Horbo专注于我们擅长的专业领域，并受益于自身深厚的行业实践体验和独到的专家经验。顾问团队大都成长和历练于特定的行业领域，对所服务的行业市场、行业动态、商业运作模式与企业运作流程、企业背景与文化、企业组织与职能配置、市场人才供需状况、人才薪资水平等有深刻的把握。我们的行业优势如下：
金融投资（证券、基金、资产管理、信托、银行、保险、PE&股权直投、供应链金融）
数据科学(市场研究、Big Data、数据挖掘、AI、软件研发）
消费健康（快速消费品、零售\生物技术、医疗器械、医药）


    公司通过开放思维、创新、勇于挑战极限，构建不拘形式和信任的环境。我们嘉奖进步，颂扬成果，追求完美，视为企业生命，并用品质去推动公司和员工共同成长。
   我们以赢得客户满意和尊重为核心目标，并不断更新和完善项目和服务实施，确保客户永远是其***受益者，以极大的热情全力以赴地推动客户成功。

   我们与客户建立起一个长期的双赢合作关系，同时与职业精英也保持密切联系，为他们职业生涯的良好发展提供支持与帮助。

    上海办公地址位于静安寺-中山公园商业圈，距离地铁2号线、11线江苏路站10分步程，写字楼附近有包括71路中运量公交等20多条公交线路。

Horbo specializes in providing search, assessment and career consulting for senior level management resources and specialized field professionals. With headquarters in China Shanghai, offices and partners in national wide and global, we operate nationwide and international network with partners in many countries and regions.

Horbo is dedicated to offering a first class service to both clients and candidates alike. The solid knowledge and extensive practice of various industries and market sectors enables Horbo to offer high quality services in searching for the right candidate or helping you secure your next career move.