北京招聘

The Regulatory Affairs Manager assists with the regulatory maintenance of a portfolio of products.  This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. The Regulatory Affairs Manager will assist the line managers on specific projects, and in some instances will be responsible for their own projects. To ensures that each project operates within the set timeframes, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Zailab Standard Operating Procedures. May also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.
职位要求：
1. Tertiary qualifications in pharmacy or a science degree with a pharmacology major
2. At least 5-7 years experience in regulatory affairs working, drug and/or medical device
3. Good working knowledge of international and local regulatory guidelines and codes
4. Proficiency in Basic Microsoft Word, PowerPoint and Excel

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。