Head of Regulatory Affairs
15000 人民币~20000 人民币/每月
全职
5~10年
刷新于 3 个月前
202 查看
44 申请
北京
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职位职责
Provide strategic support for pharmaceutical affairs, clinical and product registration of products at different stages, including but not limited to product strategy, regulatory requirements for clinical research and marketing approval in domestic and international markets, regulatory strategy and risk assessment, advice on interaction with health authorities, etc.
Extensive knowledge of regulatory requirements in China, the United States, the European Union, Japan and other regions, and the ability to address key regulatory issues for clinical programs and marketed products from a strategic and operational perspective to support corporate objectives.
Liaise and negotiate with regulatory authorities on all aspects of drug development as needed to expedite approval.
Maintain awareness and sensitivity to the global regulatory environment and assess the impact of changes in regulatory standards on business and product development plans.
Build partnerships with key stakeholders across sectors, engage in project collaboration, negotiation and DD, and provide regulatory leadership.
Responsible for establishing the global registration and declaration platform system.
Recruit, develop, manage and direct regulatory professionals to carry forward the company's mission and culture.
职位要求
Education and major: Bachelor degree or above, major in biology or pharmacy
Professional knowledge: Familiar with clinical development strategy, experience in non-tumor or tumor drug registration from early stage to market, proficient in Chinese, US and European registration regulations and technical guidelines
Work experience: at least 5-10 years of international registration experience, innovative drug MRCT development experience, made local products to the sea (at least 1-2 approved new drugs in Europe and the United States)
Skills required: Fluent in both Chinese and English, both written and written
Other requirements: Excellent organizational communication and coordination skills
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