苏州招聘

• Adherence to Zailab and industry code of conduct, ethics and good regulatory practices including RA SOPs and other required SOPs.
• Align with the values and vision of Zailab
• Maintain regulatory compliance (PI & CMC) with Local legislation, Global regulatory policies, Zailab code of conduct
• Maintain company confidentiality (i.e. intellectual property, product information and strategic information)
• Disclose potential breach of codes or conduct
• Follow SOP requirements especially on documentation
• Implement regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch.
• Coordinate with key stakeholders (local regulatory authority and local MC etc.) to achieve rapid/ high quality submissions and approvals
• Prepare and produce high quality regulatory submissions
• Monitor registration process and promptly report whenever necessary
• Actively communicate with CDE reviewers for technical discussion and Panel Meeting 
• Maintain product licenses through timely renewal to high standard
• Monitor and promptly report status of all product licenses
• Implement submission plan for products maintenance (license, amendments to update registration files etc.) as approved and deliver plans on time
• Maintain complete documentation records.
• Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholders
• Maintain and update local and global regulatory support and information systems
• Communicate changes to regulatory status to all stakeholders
• Provide appropriate support to other functions
• Under supervision: establish relationship with local regulatory authorities.
• Build up Zailab’s good image through high professional standard of application, response to enquiries etc.
• Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives or trainings
• Monitor local regulatory environments and communicate to key stakeholders, support to exert regulatory influence through company initiatives and/or industry association joint forces.
• Maintain up-to-date knowledge of local regulatory environment
• Communicate changes of local regulatory environment

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。