1. Be engaged in the domestic and international registration of the drugs (genetic drugs, protein drugs), sorting, writing and translating the registration materials according to the relevant requirements, and conducting technical evaluation of the registration materials, which meet the requirements of application; Communicate with FDA and domestic and foreign drug authorities, follow up the progress of projects, and finally obtain the relevant permission from the authorities;
2. Engage in product technology and regulatory support, such as design review of various research schemes, dynamic tracking of relevant regulations, etc;
3. Assist in organizing the review communication meeting, be responsible for the submission of registration materials, and follow up the review progress;
4. Assist in organizing registration verification until obtaining listing permission;
5. Assist in organizing the project budget, and collecting project completion indicators and budget;
6. Be engaged in the drafting, designing, reviewing of package labels of product specifications;
7. Review quality, registration, pharmacovigilance, production technology agreement, etc;
8. Assist the superior in project research, evaluation and registration implementation according to the relevant specifications.
1. Bachelor degree or above in Pharmacy (pharmaceutical preparation, pharmaceutical analysis, or medicine (Pharmacology, toxicology or clinical) or other related majors;
2. More than 1-2 years of experience in new drug research and development or drug registration, and experience in China-US reporting is preferred;
3. CET-6 or above, good English reading, domestic and foreign literature query ability, excellent oral English or overseas study is preferred;
4. Be familiar with CMC and quality；
5. Be practical and reliable, have good communication skills and team spirit, have a strong sense of responsibility, be careful and patient.
If you are interested in joining us, please send your full resume and application to firstname.lastname@example.org or submit it via the contact form.
Attachment（pdf only.Max 2MB）