北京招聘

岗位职责： 

?Propose registration strategy of drug products in China, Asian countries and America, including timeline, budget and acquire agreement of related stakeholders 

?Collect information of drug registration regulations, guidelines, change trend and share with the team 

?Build and maintain good relationship with health authorities, as well as keep effective communication 

?Support R&D team to conduct the studies according to related regulations and technical guidelines 

?Be responsible for the organization, monitoring of pre-clinical, clinical and other related outsourcing researches, to fulfill regulations requirements 

?Complete registration dossiers by guiding related stakeholders 

?Review of technology transfer documents and change controls. Ensure submission of satisfactory and timely responses to deficiency letters 

?Be responsible for organization, coordination, implementation of authorities’ inspection according to registration-related regulation 

?For licensed products, prepare and co-ordinate timely submission of post licensing commitments and legal obligations of the Marketing Authorization Holder via appropriate procedures, e.g. renewals, annual reports, variations, responses to questions, PSURs etc. 

?Ensuring the upkeep of regulatory databases 

?Other job assigned 

任职资格： 

?Bachelor of pharmacy degree or above 

?At least 8 years of experience in drugs registration 

?Fluent in oral English and effective communication 

?Strategic thinking and good planning skills 

?Performance driven 

?Self-motivated and able to motivate the team.

多年来一直专注于于为世界500强，跨国公司，国内上市公司提供管理咨询，人力资源咨询和中高端招聘服务，为中高级职业经理人提供更好的职业发展机会。
在中国服务力量遍布在北京、上海、广州、深圳、成都、南京、宁波、苏州等多个城市, 超过100名专业咨询顾问。