Regulatory Affairs Specialist 北京

月薪： 15-20万/年

该公司所有职位
  • 无工作经验
  • 招1人
  • 12-20 发布

职位描述

Major Accountabilities?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;?Get involvement in Product Launch Velocity to assist marketing launch the product in China;?Assist distributor to resolve the on-port testing for drugs and other related issues;?Closely work with global & regional regulatory personnel to ensure the clear & smooth communication & request;?Maintain the close working relationship with SFDA, testing labs and other government agencies;?Keep Marketing/Sales team updated with regulatory status to become a business partner;?Assist Marketing/Sales team for post market surveillance, products promotion and market supportIdeal BackgroundEducation:Must Have:Bachelor’s degree or upwards with medical / pharmaceutical major is required.Languages:Excellent verbal and written communication & presentation skills in English                                          Experience/Professional Requirement:3- 5 years of regulatory experience in multi-national pharmaceutical industry.Ability to work cross functional and business teams, good communication and interpersonal skills that can influence decision-making in a professional manner. 职能类别： 医疗器械注册

联系方式

新恒基国际大厦12楼

公司信息

爱尔康（中国） 作为全球眼科领域的领导者，爱尔康的使命是通过创新型产品，提高视觉质量，提高生活品质。这个使命意味着爱尔康22000多名员工为“保护、恢复和提高视力”的目标进行着不懈的努力与奋斗,使散光治疗，青光眼治疗，近视眼激光视力恢复矫正等等技术得到更好，更全面的普及，努力改善更多人的视力健康。 诺华和爱尔康合并后，爱尔康、视康和诺华眼科的优势融合到同一眼科保健业务，爱尔康已成为诺华集团第二大业务部门。公司合并带来的整合资源和业务覆盖的优势，爱尔康现在180个国家销售全线的眼科保健产品，包括手术产品、药品和视力保健产品，并在75个国家拥有分公司。 从一个孩子为矫正近视眼配的第一副隐形眼镜，到她的祖父母为治疗白内障而做的人工晶体植入，爱尔康的创新产品帮助各个年龄段的患者更清晰地看到世界。爱尔康的产品与高科技可用于解决诸多领域里日益增长的临床问题，例如白内障、青光眼、视网膜疾病、屈光不正、眼部过敏、眼部干涩、感染和发炎以及许多其他眼部护理需求。 在全球范围内，爱尔康有近2000名员工致力于研发工作，以满足世界上最迫切的眼部护理需求。同时，我们的业务也延伸到专业教育领域并在整个行业内处于领先水平。

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周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南

企业入驻日期： 2017-11-09

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