I. Responsible for pharmaceutical and non-clinical research of drugs, and new drug registration management in the whole process of clinical research

1, according to domestic and foreign registration requirements, put forward reasonable pharmaceutical, non-clinical research, clinical research programs and requirements;

2. Manage the whole process of research projects with registration as the goal;

3. Responsible for pre-clinical and pharmaceutical technology outsourcing management;

4, responsible for regularly collecting and sorting out the registration progress information of competitive products;

5. Responsible for completing the communication with the regulatory authorities on key technical issues, writing application materials, submitting registration applications, registration communication, reply to review questions, on-site inspection and other registration work。

Ii. Responsible for the related work of the company's pharmaceutical administration

Responsible for the company's communication with domestic and foreign drug regulatory agencies and review experts, establish direct communication channels, and maintain good relations。

3. Complete other tasks assigned by leaders。

1, medicine, pharmacy, biology and other related majors;

2. Master degree or above;

3, engaged in drug registration work for more than 5 years, with successful clinical registration strategy or biological products marketing registration related work experience is preferred;

4, familiar with the regulatory requirements for communication with the drug administration department, master the skills of preparing communication materials, with direct communication channels with the regulatory department is preferred;

5, with good communication and research skills;

6. Have good professional ethics, excellent problem solving ability, public relations ability and emergency plan management ability, strong team spirit and communication and coordination ability;

7. Can adapt to travel。