• Categories:Recruitment
• Author:
• Origin:
• Time of issue:2018-09-29
• Views:58

(Summary description)
Job Responsibilities:

1. Responsible for the preparation and arrangement of the registration application materials of the company's API products in the United States, the European Union and other countries and regions;

2. From the beginning of the small test to the project declaration, keep in touch with the company's project research and development department, and track and supervise the project progress;

3. Through various channels, master the drug registration policy and variety trends, and handle the drug registration in a timely manner;

4. Master the requirements of CDE for registration materials, and understand the relevant guiding principles of ICH and FDA for drug registration;

5. Have good communication skills, organizational coordination skills and teamwork awareness.

  job requirements:

1. Bachelor degree or above in pharmacy, biopharmaceutical and other related majors, more than one year related work experience;

2. Familiar with the drug registration process, excellent English writing skills;

3. Familiar with the laws and regulations related to drug registration, and provide policy support for the establishment of new products.