Director of Drug Registration

2024-09-18

Responsibilities:

1. Collect, sort, and organize the necessary pre-IND/IND documents and materials, timely identify critical issues in registration application processes and propose solutions, and coordinate and resolve them with related departments; be responsible for the progress of the corresponding projects, and promote the registration progress of the submitted products.

2. Communicate with the Drug Evaluation Center of the National Medical Products Administration (NMPA) to address the issues raised during the registration process, and resolve the regulatory and registration issues encountered during drug development and registration;

3. According to the requirements of the company's project registration schedule, organize and coordinate the work progress of various departments to ensure that the compilation of application materials is completed on time;

4. Familiar with relevant laws and regulations and approval procedures, responsible for obtaining relevant drug registration information, , reviewing and submitting drug registration materials, writing relevant application technical documents according to application requirements, and completing domestic and foreign drug application, data supplement, change, annual report submission and other work;

5.Understand the project progress of competitive enterprises and track the information of competitive products; Timely track and grasp the changes of international registration regulations, timely adjust registration strategies and plans.

Requirements:

1.Master degree or above in pharmacy, biology, pharmaceutical and other related majors, with about 10 years of working experience, and experience in antibody or biological macromolecule innovative drugs is preferred;

2.Familiar with domestic and foreign drug registration workflow, international registration experience, familiar with FDA and other relevant regulations and actual declaration process is preferred; Experience in the fields of tumor or metabolism diseases and experience in leading an entire biologic new drug project registration is preferred;

3.Excellent bilingual ability in Chinese and English, keen ability to retrieve and acquire literature and other materials;

4.Excellent communication, strong teamwork and management skills, good senses of responsibility and initiative.