Job Responsibilities:

1. Responsible for formulating microbial drug application plan;

2. Collect and sort out the preclinical research, production process, IIT clinical and other data of the research project in accordance with the application requirements, including formal review and part of the technical review, to ensure the integrity and compliance of the data, and to ensure that the data meets the application requirements;

3. Responsible for assisting clinical research management, and supervising clinical trials directly or through CRO companies;

4. Track the dynamics of domestic and foreign regulations and technical guidelines.

Qualifications:

1. Master's degree or above in pharmacy, medicine, biology or related majors, with more than 5 years of experience in new drug application;

2. At least two or more biological drug varieties have been declared;

3. Familiar with new drug registration regulations, systems and application procedures;

4. Have a strong sense of responsibility, good communication skills and teamwork spirit.