Drug registration and entry

Drug registration/Pharmaceutical vigilance post (Hong Kong)

Job Responsibilities

1. According to the company's product characteristics and R&D stage, participate in the formulation of registration application strategies and plans, collect, organize and submit application materials for drug registration in accordance with the relevant requirements of domestic and foreign drug regulatory agencies, and promptly file after submission;

2. Responsible for following up on drug registration progress, communicating and exchanging with drug regulatory agencies, responsible for information transmission and response, and ensuring timely filing of approval information and documents;

3. Local market sales work, assist in organizing and implementing various academic conferences and product promotion activities, and timely and accurate feedback market information;

5. Data statistical analysis work, including but not limited to statistical collection of customer complaint and feedback information, risk analysis of various types of failure modes, regular trend and review analysis of complaint data, and formation of reports.

Job Requirements

1. More than 2 years of relevant work experience, with pharmacy as the preferred field;

2. Familiar with domestic drug registration-related policies and regulations, technical requirements, application procedures and application material requirements, etc., have a certain understanding of foreign (such as the United States and the European Union) drug registration-related laws and regulations, and have the ability to search and analyze drug registration information;

4. Able to independently review domestic and foreign relevant literature, with English listening, reading and writing abilities.