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Approval manager

作者:超级管理员发布时间:2021-10-27 09:17:10

Job name: Approval Manager

Recruitment Number: 1

Monthly salary range: 20-40K (annual salary)

position statement:

1. is mainly engaged in domestic registration and international registration affairs such as drugs and medical devices, organizing, writing, translating registration materials in accordance with relevant requirements, and technical review, evaluating the application requirements; communicate with foreign enterprises and domestic and foreign drug authorities, follow up the progress of drug projects and finally obtain permission from relevant authorities;

2. is engaged in product technology and regulatory support affairs, such as design review of various research schemes, dynamic tracking of relevant regulations;

3. works in pharmacovigilance at home and abroad;

4. is engaged in the drafting, design, review and release of product specification packaging labels;

5. audit quality, registration, pharmacovigilance, production technical agreements, etc.;

6.Research and evaluation work of new products.

7. provides data and technical support for drug option approval.

8. is responsible for the BE filing and registration of generic drugs in Shandong factory.

Job requirements:

1. pharmacy (pharmacy preparation, drug analysis and pharmacy English are preferred) or medicine (Pharmacological toxicology or clinical), with a master's degree or above

2. with more than 3 years of experience in new drug research and development or drug registration is preferred;

3. English level 6 or above, strong listening, speaking, reading and writing ability, fluent and smooth English communication with English, excellent oral English or overseas learning and work background is preferred;

4. has good communication skills and team spirit, with a strong sense of responsibility, careful, patient, and positive progress.

Company address: Su Research Institute, Institute of Medicine, Chinese Academy of Sciences, No.108, Yuxin Road, Suzhou Industrial Park, Jiangsu Province

Received Resume email box: L705003135@outlook.com

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