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Manager, Regulatory Affairs-Onco ID166858
2-4万
人 · 本科 · 5年及以上工作经验 · 性别不限2024/07/03发布

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, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.

Job Responsibilities:
- 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.
- Registration dossier management.
- Involve in devising strategies.
- Implement DRA SOP.
- Other harmonization work in DRA.

Requirements:
- Bachelor degree or above, with a major/focus on Pharmaceutics, Chemistry, Biology and other relevant major.
- At least 5+ years of import drug registration working experience.
- Good project management skill and experience. Be able to work with a keen sense of urgency and priority. Strong learning ability.
- Good relationship & experience with relevant authorities is preferred.
- Good personality with team spirit.
- Interpersonal and communication skill are also required.

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