苏州招聘

1. This position is to set up / maintain regulatory system.
2. Regulatory document archiving and ensure the regulatory compliance with the Good Regulatory Practice as well as to meet global and local regulatory requirements.
3. Adherence to Zailab and industry code of conduct, ethics and good regulatory practices including RA SOPs and other required SOPs.
4. Support China eCTD project to make sure the project smoothly implemented. Make sure China submission template readiness on time and user training finished before China eCTD project implemented.
5. Other tasks assigned by Manager.
职位要求：
1. Bachelor or above in Pharmacy, Medical, Biology or related field.
2. > 2 years’ experience in specialist positions.
3. Chinese and English (proficiency level).
4. Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。