Regulatory Affairs Specialist
爱尔康(中国)眼科产品有限公司
- 公司性质:外资(欧美)
- 公司行业:医疗/护理/卫生
职位信息
- 发布日期:2020-12-08
- 工作地点:北京-朝阳区
- 招聘人数:1人
- 工作经验:2年经验
- 学历要求:本科
- 职位月薪:1.5千以下/月
- 职位类别:其他
职位描述
· Prepare the registration submission for CTA, NDA, license renewal and variation according to SFDA requirements and company plan;
· Ensure the new products application, license renewal and variations registration are managed according to the timeline specified in the reporting period.
· Assist RA Manager to set up registration strategy and registration plan for each application.
· Double check registration dossiers to ensure them meet both SFDA requirements and CDE guidance;
· Monitor the whole registration process to ensure the process going smoothly;
· Registration status feeding back timely from both SFDA testing labs and CDE to accelerate registration process;
· Be aware of government regulation & human resources change in advance to prevent unfavorable decision which will impact new product launch and marketed product;
岗位要求:
· Bachelor’s degree or upwards with medical / pharmaceutical major is required.
· Excellent verbal and written communication & presentation skills in English
· 1- 3 years of regulatory experience in multi-national pharmaceutical industry.
职能类别:其他
公司介绍
爱尔康于1995年成立中国公司,致力于为国内眼科专家、患者和消费者提供更好的解决方案。爱尔康中国不仅提供创新的产品和服务,还竭诚为国内眼科医生打造国际化的学习交流平台,积极推动中国眼科事业的发展。此外,企业还同眼科基金会等慈善机构紧密合作,支持各类扶贫项目,为中国的防盲治盲工作贡献力量!
2019年4月,爱尔康在瑞士证券交易所和纽约证券交易所同步上市。企业持续秉承对客户、患者和消费者的承诺,通过引领眼科及视力保健产品的突破性创新改善视觉质量,提升人们的生活品质,与大家一道共见精彩!