Job responsibilities:

1. Responsible for following up and managing the progress of registration and application of innovative drugs, carrying out drug review process and registration procedures;

2. Responsible for proposing project registration plan and supervising its implementation, responsible for writing the non-clinical part of IND application documents according to domestic and international regulatory requirements, supervising and reviewing other drug registration application documents;

3. Coordinate with FDA, CFDA and other relevant review and regulatory authorities, third-party certification bodies, etc.;

4. Organize and arrange on-site inspection of drug registration and coordinate with various departments to answer questions raised by on-site inspection personnel;

5. Assess the compliance of all phases of drug research and issue recommendations for action according to the relevant regulations of the drug regulatory authorities;

6. Responsible for tracking and collecting domestic and international drug regulatory policies and regulations, establishing policy information databases, and timely updating and organizing internal training;

7. Responsible for the gap analysis of the non-clinical part of innovative drug product application;

8. Other matters assigned by the leadership.

Job requirements:

1. Holders of master’s degree or above in pharmacy, pharmacology, pharmacokinetics, toxicology or other related majors or holders of bachelor’s degree with rich experience matched with this post;

2. More than 2 years of experience in new drug registration and application, or new drug development (especially non-clinical research); domestic and foreign IND registration and application work experience preferred;

3. Master drug development, clinical trials and international and domestic regulations and other related knowledge;

4. Familiar with IND application and registration regulations concerning biological drugs and preparation of IND application documents, experience in participating in IND or NDA application;

5. Excellent oral communication skills and professional writing skills in English and Chinese;

6. Proficient in use of OFFICE software, strong independent learning ability and information collection, analysis, aggregation ability.