职位描述

?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

任职条件

?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

上班地址：东大桥路8号尚都国际中心A座1703