Job Responsibilities
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.
Job Requirements
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
Required Languages
Mandarin, English
Job Details
Position type
Other
Experience
5～10 years
