岗位描述
在罗氏,我们鼓励每位同事展现真实的自己;我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结,在这里,你将因为做自己而被重视、接纳和尊重,并得到个人的提升和职业的发展。所有的这一切,都是为了更好地预防、阻止和治愈疾病,并确保医疗资源的可及性和可持续性。欢迎加入罗氏,一个重视每种声音的地方。
职位
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
Your Opportunity
You will be filling the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP manner.
You will make sure the accuracy and truthfulness of the registration dossiers. Maintain the registration and approved dossiers per company requirements.
You will be per company requirements, cross check for the registration dossier to make sure the accuracy and truthfulness of the registration dossiers.
You will establish and maintain the good and closed relationship with NMPA testing centers. And successfully gains product QC testing reports per registration forecast plan.
You will close working together with CO and CCOE team to provide the regulatory supports on time.
You will provide the cross cooperation with other departments
You will establish and maintain the good relationship with key contacts. Recommend valuable suggestion to company.
Who you are
You hold bachelor degree or above, relevant subject on medicine/bioengineering/clinical medicine/ biochemistry or pharmacy.
You have not less than 2 years’ experience in medical regulatory affairs, focusing on testing center and clinical trial, and familiar with NMPA Standards and guidelines.
You are familiar with relevant NMPA registration regulation and policies.
You are familiar with English communication at the workplace
You are good skill on computer, MS-Office operation.
You are willing to work under pressure, self-starting and self-inspiring
我们是谁
打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学,确保今天和明天的人们,都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗,我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案,对全球的医疗环境带去推动和影响。
让我们一起,构建更健康的未来。
罗氏提供平等的职业发展机会。