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Associate Manager, Regulatory Affairs ID173807
2-2.5万
人 · 本科 · 5年及以上工作经验 · 性别不限2024/10/21发布
周末双休工作餐

北京市

公司信息
勃林格殷格翰(中国)投资有限公司

外资(欧美)/10000人以上

该公司所有职位
职位描述
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.

Job Responsibilities
- To organise & implement the registration work based on China’s registration regulations with the objective of meeting Boehringer Ingelheim China's products registration timeline.
- Work independently on projects, communicate with HQ of company to request registration documents and samples.
- Prepare and submit the registration dossier for new products, IDL renewal and variation application.
- Follow up and push QC test, CDE review & NMPA approval process to obtain the approval timely.
- Registration dossier management
- Implement DRA sop.
- Other harmonization work in Drug Regulatory Affairs.

Job Requirements
- Bachelor degree or above (e.g. MBA, MSc), major in Pharmaceutics, Chemistry, Biology or other relevant major is preferred.
- At least 5 years import drug registration working experiences.
- Good project management skill and experience. Be able to work with a keen sense of urgency and priority.
- Good relationship & experience with relevant authorities is preferred.
- Good personalities with team spirit.
- Good interpersonal and communication skills.
- Strong learning ability.

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