Senior Specialist, Regulatory Affairs 北京

月薪：

该公司所有职位
  • 3-4年经验
  • 硕士
  • 招1人
  • 12-21 发布
  • 五险一金
  • 通讯补贴
  • 定期体检
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 交通补贴
  • 补充医疗保险

职位描述

This position will conduct registration biological products for China market. This person will work collaboratively with Commercial Marketing, Global Regulatory Affairs and external distributors. This position will need to keep in touch with Chinese government authorities and agencies.1.Key Responsibilities：?Work closely with MSD AH Global RA colleagues in preparation of dossiers and documents to get products registered in China. Provide Global RA with guidance and regulations required by China authority for the documentation preparations?Work closely with internal colleagues of MSD AH China to ensure that product registration in China is valuable and meets the requirements and timelines?Keep touch with China authorities and agencies, such as MOA, IVDC to track the registration process. And work with Global RA to prepare the answers for the question if needed.?Interface and collaborate with MSD AH distributors and product importers in preparation and providing necessary documents and test results in the sample and product import ,and product marketing?Assist the supervisor in problem solving, preparation of study contracts, and external services, etc.2.Key Relationships:Internal:?Global RA, collaboration, providing Chinese regulations and guidance?Supply Chain and each BU, to ensure product import and timelines?Internal RA team collaboration for the relevant workExternal:?China Authorities and agencies for foreign product registration?MSD AH China distributors and product importer3.Person Specifications:Essential：①Education：MS degree; Prevention Veterinary Medicine②Experience：2-3 years of direct regulatory affairs experience in veterinary products, R&D, QC,QA, CA or veterinary production, preferred experience in veterinary registration for foreign company. Especially registered one product or leaded one R&D project is much better.Professional and scientific interface established within both professional societies and animal health authorities.③Skill ：Familiar with oral English and writing EnglishDesired：①Education：Ph.D. degree; Prevention Veterinary Medicine②Experience：3–5 years of direct regulatory affairs experience or R&D experience in veterinary products, preferred experience in veterinary drug registration for foreign company. Especially registered one product or leaded one R&D project is much better.Professional and scientific interface established within both professional societies and animal health authoritie③Skill ：Excellent skill for oral English and writing English 职能类别： 药品注册 关键字： 药品注册 政府事务 医药 法律 动物医学

联系方式

望京研发创新基地

公司信息

今天的默沙东正致力于为全世界带来健康的福音。我们为全球140多个国家提供药物、疫苗、生物制剂、健康消费品和动物保健产品，并与客户一起提供创新的健康解决方案。同时，我们还致力于通过各种意义深远的项目向需要帮助的人们捐赠和提供产品，从而扩展人们进入医疗卫生的途径。默沙东，健康是福。 默沙东中国的总部设在上海，目前中国大陆地区共有10个分公司和3座工厂，分别在上海，杭州和南京。员工总人数超过5100人。 目前，我们在中国提供涵盖心血管、抗感染、***健康、女性健康、骨科、疼痛、皮肤、呼吸、专科药品、辅助生殖、疫苗等领域的46种人用药品。默沙东在中国建有三座工厂，拥有技术水平领先全球的生产设施，一流的环境标、优秀的生产工人以及高水平的管理能力，符合中国药品生产质量管理规范（gmp标准）。我们还向中国市场提供46种动物健康产品，用以预防、治疗和控制家禽家畜以及宠物的疾病。 “我们应当永远铭记，药物是为人类而生产，不是为追求利润而制造的。只要我们坚守这一信念，利润必将随之而来。仅仅发明了一种新药，并非已经大功告成，我们还要探索有效途径，使默沙东的***科研成果，能够造福于全人类。” 乔治默克 一九五零年十二月一日 我们的事业是救治人类生命、提高生活质量，同时改善动物健康 我们坚持最高的道德与诚信标准 我们致力于不断提高科学研究水平，以改善人类与动物健康、提高生活质量为己任 我们希望的利润，全部来源于满足客户需求，并用于造福社会 我们相信公司的成功取决于员工的诚信、知识、想象力、技能、多元化以及团队精神 员工是默沙东最宝贵的财富之一。我们坚信，企业的成功归功于每一位员工的诚信、学识、敬业度和责任感。在中国，默沙东注重通过推行完备的人才管理体系，不断提升员工积极性和工作绩效，使他们能够充分发挥才能，并享受工作带来的成就感。 广纳良才 —— 寻找、吸引拥有丰富技能和正确职业态度的***人才 激 情 —— 创建独到的企业文化，让每一位员工充满激情，并且乐于分享企业的价值观和目标 发 展 —— 创建一种持续学习的环境，让每位员工做到更好 激 励 —— 对员工做出的贡献进行奖励

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