Job Responsibilities：

1. Responsible for the domestic and international registration filing of products of the company. Write, summarize and organize registration documents, and review the completeness and authenticity of project documents;

2. Responsible for the progress of corresponding projects, effectively promote the new drug declaration and launch, promptly follow up and obtain regulatory information of major countries and regions, and provide regulatory support for drug development, registration and whole life-cycle management；

3. Responsible for handling unexpected events promptly and reporting to superiors in time；

4. Responsible for the integrity and authenticity of the corresponding project information verification work；

5. Responsible for communication and consultation with domestic and foreign registrars, agents and regulatory agencies for corresponding projects；

6. Responsible for the preparation, improvement and upgrading of SOPs of preclinical development department and reporting to superiors for audit；

7. Responsible for the training of regulatory knowledge for relevant staff and the development and implementation of training plans；

8. Coordinate pharmacy, preclinical and clinical registration filings and communication with registration agencies；

9. Cooperate with other departments for project research and consultation.

10. Other tasks assigned by the supervisor；

Qualification Requirements：

1. Education requirements: Master's degree or above in pharmacy, pharmacology, biology or related majors, PhD degree or overseas study and work experience is preferred；

2. Work experience: more than 5 years of relevant work experience in pharmaceutical, drug R&D or CRO companies, with successful experience in drug declaration and registration is preferred；

3. Familiar with drug registration regulations, standards and other information of major countries and regions；

4. Excellent English listening, speaking, reading and writing skills, and can fluently review, write and audit all kinds of literature, materials and reports；

5. Strong drug registration experience and management experience, with relevant experience in conducting training and hosting meetings；

6. Clear written and oral presentation skills, able to independently review relevant literature, write and review various reports；

7. Strong execution skills, stress tolerance, ability to work independently, excellent problem solving skills and emergency plan management skills；

8. Have a good sense of entrepreneurial spirit, love and favor the industry, and have good professional ethics and dedication。