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
Bachelor of pharmacy degree or above
At least 8 years of experience in drugs registration
Fluent in oral English and effective communication