Professional：

 1. At least 2 years of experience in chemical drug submission and registration, with responsibility for or substantial participation in NDA submission and registration; experience in clinical‑stage drug registration is preferred.

2. Bachelor's degree or above in pharmacy or a related field.

3. Familiar with registration regulations, technical guidelines, and relevant guidance documents of CDE, FDA, and other regulatory agencies.

4. Good command of English listening, speaking, reading, and writing; proficient in using CDE electronic submission software and eCTD.

5. Strong writing skills, communication and presentation abilities, and team collaboration.

6. Rigorous work style, high sense of responsibility, ability to work under pressure, and capable of completing assigned tasks independently.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Independently draft and review non-technical documents in accordance with current regulations, and review technical documents for compliance and completeness.

2. Responsible for drafting, reviewing, and submitting registration dossiers; follow up on registration testing, registration verification, and the review and approval process.

3. Develop project registration work plans to ensure timely completion of all registration‑required tasks.

4. Communicate with regulatory authorities on submission and registration matters, and promptly resolve or provide feedback on issues arising during the review and approval process.

5. Track and stay up‑to‑date with the latest NMPA/FDA regulatory policies, guidelines, and normative documents.