上海招聘

职位描述：
JOB DESCRIPTION

1. POSITION: Senior Regulatory Affairs Specialist/RA Specialist
2. FUNCTION: Registration and Clinical Development
3. REPORTS TO: Regulatory Manager
4. DIRECT REPORTS: None
5. EDUCATION: Bachelor degree in pharmacy or related science with a pharmaceutical or biotechnology major
6. LOCATION: Beijing
7. EXPERIENCE:
? Minimum 3 years working experience in pharma industry or 1 year experience in registration field in pharmaceutical or biotech industry
? Familiar with regulatory guidelines and requirements
? Good interpersonal communication skill, team work
? Good written and oral communication skills
? Fast learning capability



8. RESPONSIBILITIES:
? Perform and manage day-to-day product registration operations and ensure timely completion of the registration tasks assigned, in compliance with regulations, guidelines and internal processes
? Compile submission packages and ensure timely submission upon internal review and approval
? Prepare response docuemnts as requested by regulatory authorities
? Monitor regualatory authorities’ review and approval processes, keep manager advised of the progress, and discuss critical issues and potential solutions before implementation
? Handle QC validation testing, resolve technical issues to ensure timely completion
? Collect information on competitive products, provide regulatory supports and advices
? Maintain all regulatory documentation
? Assist manager to complete urgent assignment as requested in a time manner 举报 分享

天境生物科技(上海)有限公司
天境生物由臧敬五博士领衔的创新药资深研发团队创建，是一家聚焦在肿瘤免疫和自身免疫疾病精准医疗领域的新药研发生物医药科技公司。
公司的核心竞争力在于早期研发、靶点发现和验证、工艺开发&临床前评价、质量科学&质量管理、早期临床研究的能力（包括临床一期和临床二期）。团队在创新药物靶点生物学、创新抗体药物分子结构研发以及创新药物的转化医学及临床研究方面的优势为公司建立一条具有国际竞争力的项目管线创造了基础。公司目前创新药管线含12个在研创新抗体药物项目。领先的创新药项目将在2017年3月申报临床研究并在台湾, 韩国及中国启动临床研究, 其它项目均已进入细胞株或工艺开发阶段。
公司从成立以来已经建立了广泛深入的国际合作, 如与瑞士FERRING公司合作独家引进开发Olamkicept。公司自主研发的全球创新药项目将在2018年进入中国及美国临床研究申报环节并计划在两地启动一期临床研究。