(Senior) Regulatory Affairs Manager
爱尔康（中国）眼科产品有限公司
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2015-07-10
- 工作地点：北京-朝阳区
- 招聘人数：2
- 学历要求：本科
- 职位类别：药品注册 医疗器械注册
职位描述
? Manage the registration process for CTA, NDA, license renewal and variation of 2-3 Therapeutic Areas according to CFDA requirements and company plan, to ensure smooth and timely approval;
? To set up registration strategy and registration plan for each application;
? Double check registration dossiers to ensure them meet both CFDA requirements and CDE guidance;
? 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;
? Closely work with global & regional regulatory personnel to ensure the clear & smooth communication & request;
? Maintain the close working relationship with CFDA, 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 support
Education:
? Bachelor’s degree or upwards with medical / pharmaceutical major is required.
Languages:
Excellent verbal and written communication & presentation skills in English.
Experience/Professional Requirement:
? At least 5 years of regulatory experience in multi-national pharmaceutical industry;
? People management experience is preferred;
? Ability to work cross functional and business teams, good communication and interpersonal skills that can influence decision-making in a professional manner.
? Excellent verbal and written communication & presentation skills in English.
? Provide technical support and comments to Novartis & CFDA with Chinese Pharmacopeia discussion
? To set up registration strategy and registration plan for each application;
? Double check registration dossiers to ensure them meet both CFDA requirements and CDE guidance;
? 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;
? Closely work with global & regional regulatory personnel to ensure the clear & smooth communication & request;
? Maintain the close working relationship with CFDA, 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 support
Education:
? Bachelor’s degree or upwards with medical / pharmaceutical major is required.
Languages:
Excellent verbal and written communication & presentation skills in English.
Experience/Professional Requirement:
? At least 5 years of regulatory experience in multi-national pharmaceutical industry;
? People management experience is preferred;
? Ability to work cross functional and business teams, good communication and interpersonal skills that can influence decision-making in a professional manner.
? Excellent verbal and written communication & presentation skills in English.
? Provide technical support and comments to Novartis & CFDA with Chinese Pharmacopeia discussion
公司介绍
爱尔康（中国）眼科产品有限公司诚聘