Pre-clinical registration declaration

  • Time of issue:2021年09月28日
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Pre-clinical registration declaration

  • Time of issue:2021-09-28

Job Responsibilities

1. Support the preparation of registration documents and registration inspection;

2. Support registration, declaration and issuance of supplements;

3. Support the research plan design and clinical institution screening of clinical trial projects;

4. Support researcher communication, seminar organization, and ethical review application in the early stage of the trial;

5. Support the monitoring, quality control, follow-up and visit during the experiment;

6. Support the data transfer and clinical trial report after the trial;

7. Continue to promote the implementation of laws and regulations within the company, and continue to influence company employees to enhance their awareness of laws and regulations;

8. Understand and follow the quality management system, quality manual, quality policy, quality objectives and applicable laws and regulations;

9. Complete the training related to the quality system and regulations on time.



1. Bachelor degree or above, major in biology, medicine, chemistry, etc., master degree is preferred;

2. Familiar with laws and regulations in gene therapy;

3. Good communication skills, written and oral presentation skills.


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