What do I need to know and prepare for applying for a drug registrar?

Duties and tasks of the Commissioner for Narcotics Control

Reprinted in Jianyou Medicine, this official WeChat account is a partner specializing in medical job hunting.

Master and apply relevant laws and regulations.

1. Seriously study and master the relevant policies and regulations such as the Measures for the Administration of Drugs and the Measures for the Administration of Drug Registration formulated by the National Bureau and the Provincial Bureau, as well as various rules and regulations formulated by the company; ?

2. Skillfully fill in registration software and skillfully use office software;

3. Keep in touch and communicate with the relevant national and provincial drug administration and drug inspection departments at any time, so as to grasp the latest policy information and feed back the relevant information to the relevant departments of the company in time? ;

Implement product registration declaration and data archiving.

1. Responsible for drafting, collecting, sorting and preliminary examination of registration application materials.

2. Ensure the completeness, correctness, authenticity and timeliness of the application materials, and notify the relevant personnel of the company to supplement them in time if any deficiency is found.

3. Submit the application materials to the relevant state departments at all levels within the specified time.

4. Organization and coordination of sample inspection and trial production.

5. Organize and coordinate on-site inspection of declared products.

6. External tracking, coordination and communication of sample registration and inspection.

7. The company's existing varieties of packaging, labels and instructions and other supplementary applications for the record.

8. Follow up the application materials in the review and approval stage, and feed back the review information of relevant varieties to the department heads and relevant personnel in time, so as to supplement the materials in time.

9. Be responsible for filing and keeping confidential the application materials.

Work cooperation relationship:

Internal coordination: all departments of the company

External coordination: US Food and Drug Administration

Competency requirements:

Good English listening, speaking, reading and writing skills and good communication skills;

Familiar with computer office software, can make forms;

Familiar with the latest laws and regulations on the registration of surgical instruments in gastroenterology;

Familiar with "Registration Management Measures" and other relevant laws and regulations, familiar with the workflow of government affairs departments related to medical device R&D registration;

Skills requirements:

Registration and clinical follow-up experience of three types of medical devices