Education and training:? Drug registration is a highly professional job, which requires the drug registrar to cover many fields such as pharmacy, pharmacology, pharmacy, biochemical pharmacy, etc., and generally requires a postgraduate degree or above in pharmacy.
Work experience: Have a full understanding of laws and regulations. In addition to being familiar with the Drug Administration Law and the Measures for the Administration of Drug Registration, it is also necessary to have a full understanding of other relevant and even non-drug legal provisions, such as the Measures for the Administration of Drug Import and the Law on the Protection of Intellectual Property Rights. Good communication and coordination skills.
Familiar with the workflow of SFDA, Institute for Drug Control and Customs, able to communicate with them at high speed and effectively. In addition, more and more enterprises, especially departments with more transnational business, require employees to have strong English listening, speaking, reading and writing skills to meet the needs of imported drugs and international clinical declaration business; Skillful use of computer office software has also become an indispensable basic condition in the information age.
To be a drug registration Commissioner, we should start with the Measures for the Administration of Drug Registration and understand the relevant guiding principles and regulatory requirements. The basic laws and regulations include the Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law. In addition, you need basic computer operation, access to the Internet, download the required software from the websites of the US Food and Drug Administration and local food and drug administrations, install and use it on your own computer, use office software to edit basic text and table files, and handle simple pictures.
Finally, there is a certain communication and coordination ability, because registration is the process from enterprise research and development to listing. You need to coordinate the company's materials, production, technology, quality and other departments to help you complete the corresponding research, and cooperate with the teachers of the Institute for Drug Control and the Food and Drug Administration to complete the examination and approval before listing. There are many details to master. A little professional and careful.
Extended data:
Career development path
At present, the technical requirements of drug research and development are constantly improving, and they are gradually moving towards the international market, so higher requirements are put forward for drug registrars.
In order to expand the development space more widely and give full play to its role, drug registration agencies should not be satisfied with mechanically registering "varieties" for enterprises, but should implement a series of orderly declaration and management of enterprise varieties, taking into account the structure of enterprise varieties, research and development direction, patent protection, standardization and improvement of standards after registration, process improvement, re-registration and re-evaluation of varieties.
Coordinate the relationship between different projects and departments, between application for registration and technical review, and between clinical research and application evaluation; Integrate the whole process from drug research and development registration to production from pharmacology, technology, socialization and management. If you can have the above qualities, plus a higher degree (master's degree or above), professional title (engineer or above) and rich first-hand research and development experience, the drug registration Commissioner can gradually develop into a drug registration manager.
Baidu encyclopedia-medicine registration Commissioner