Regulatory Affairs Specialist 北京

月薪： 0.8-1万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： RESPONSIBILITIES OF THE JOB:工作职责1.Under the general direction of supervisor, assist and support supervisor for new and marketed products:a.Develop regulatory affairs strategy and action plan.b.Compile registration dossier and ensure timely regulatory submission upon internal review and approval.c.Communicate with regulatory agencies/institutes (e.g., CFDA, CDE, NIFDC, Provincial Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.d.Timely /closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed.e.Properly maintain all regulatory documentation.2.Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets CFDA and internal requirements.3.Maintain and develop good relationships with CFDA and other regulatory authorities (CDE, NICPBP, etc.) to facilitate and expedite regulatory approvals.4.Maintain and update archiving system.5.Collect relevant information of registration and administration of medicines in China, incl. generic status, legislation, updates to the registration requirements, guidelines etc.6.Provide RA support to other functions and departments (e.g. R&D and Commercial etc).7.Collaborate with HQ RA as required.REQUIREMENT:岗位要求1.At least bachelor degree in pharmaceutical or biopharmaceutical sciences.2.At least 2-years experience in drug regulatory affairs, additional experience in drug R&D / drug manufacturing is plus3.Good understanding of the Chinese registration requirements and regulations.4.Good command of English writing, speaking/listening skill and computer operation skill.5.Good team player. 职能类别： 药品注册

联系方式

朝阳区东大桥路9号北京侨福芳草地大厦A楼12层03-06单元

公司信息

Lundbeck is a global pharmaceutical company conducting research into, developing, manufacturing, marketing, selling and distributing pharmaceuticals for the treatment of disorders in the central nervous system (CNS), including depression, schizophrenia, Alzheimer’s disease, Parkinson’s disease, Huntington's disease, epilepsy and insomnia. Lundbeck employs 5.900 people worldwide, 2.000 of whom are based in Denmark. We have employees in 57 countries, and our products are registered in more than 100 countries. We have production facilities in Italy, France, Mexico and Denmark and research centres in Denmark and the USA. Lundbeck generated revenue of approximately DKK 14,8 billion in 2010. 灵北为一家跨国医药公司，总部位于丹麦的哥本哈根，其分支机构遍布世界各地。灵北致力于治疗精神类疾病药物的研制、生产、推广及销售；尤其专注于精神病学和神经学领域。1998年灵北在北京设立代表处，并在中国不断发展壮大。现因业务扩展，规划招募如下人员，我们期待你的加入！

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企业入驻日期： 2017-11-09

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