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Who to be? Drug Registration Specialist

A typical situation for many students: you study, you study, and “who you will become when you grow up,” you do not know, even if you like the specialty. Or another frequent situation: you study, you study, but it seems that nobody needs your specialty here and now. Or you study, you study, and sadly you know who you will become, because you are sure: there are no other options after your university. Familiar? Some professions are always in sight, and we all know about them (for example, everyone has seen pharmacists in pharmacies), and some are difficult to see if you don’t work in the industry or have no friends working there. Fix that? We offer to “bring out of the twilight” the work of one of these “invisible” specialists in the outside world.

Who: a specialist in drug registration (he is also a specialist in the department of regulatory relations, a specialist in registration, regulatory affairs executive, regulatory affairs associate).

Why it is needed: in order to be in circulation in the country, the drug must be registered by the relevant government agencies. In Russia, this now means that it must be entered in the state register of medicines of the Ministry of Health of the Russian Federation and have a registration certificate. Obtaining and maintaining this status is the work of the regulatory / registration department.

What to do: the basic duties of a registration specialist usually include writing / updating normative documentation (ND), instructions for medical use (PI, IMP), models of primary and secondary packaging, complexity of the registration dossier, which contains all information on the drug, including manufacturing details, description of all components that make up the preparation, etc. Depending on how exactly the work is organized in the department, also be part of the work can be registration of maximum selling prices or interaction with laboratories conducting certification or selective quality control of drugs. How do look the instructions for use and packaging, probably, everyone knows and imagines, but what is ND? ND is a document that is confidential and does not appear in wide access, but is incredibly important in Russia and some other countries. It contains a specification for the drug (that is, a list of indicators by which the quality of the drug is controlled), its composition is indicated (this information is then transferred to the instruction for use) and describes in detail the methods used by laboratories to control the quality of the drug. In some cases, it is enough to refer to the methodology from the Russian Pharmacopoeia, in some it is necessary, based on the procedures used by the manufacturer, to create this description taking into account the existing Russian requirements. In addition, it is often necessary to update the registration dossier, for example, when changing production processes or when moving products from one production site to another. If the company sells not only medicines, but also substances, they should also be used to prepare and further maintain the registration dossier (including ND).

Where to work: many pharmaceutical companies, both Russian and foreign, have their own regulatory departments. In addition, there are firms that specialize in providing services for the registration of medicines.

Where to study: among registration specialists there are many graduates from pharmaceutical departments of medical higher education institutions (for example, MSMU named after Sechenov, RUDN), chemical universities / faculties (RHTU, MITHT (now part of MIREA), RUDN, Moscow State University). Less common are holders of diplomas of linguists / teachers, whose strength is good English, which may be important for some international companies.

What you need to know: it is necessary to have a good understanding of the requirements of Russian and Eurasian legislation, it is important (and it is critical in foreign companies) to speak English, it is very useful to know analytical chemistry and to be familiar with the methods of analysis (with practical hands-on skills that greatly simplify work and interaction with laboratories).

What you need to do and to love: you need to love accuracy, meticulousness, love to meticulously delve into documents and not rely “on chance” (as practice shows, “avosi” in this activity tend to come up unpleasantly after a few years, causing a lot of trouble drug supply), it is important to be able to analyze other people's texts and write yours well and competently. A significant factor is the willingness to constructively interact with colleagues from other departments (production, R & D, marketing, etc.) in person and by email. Another crucial aspect is the ability to organize your work and manage to do it by the deadline - many processes are tied to the harmonious work of the regulatory department, which requires long-term planning, and some deadlines are defined by law and, therefore, cannot be transferred at all.

What's next: the next career step after the specialist is the registration manager. Usually this position implies several specialists in subordination.

Where to start if you cannot immediately get this position: students or recent graduates can search for internships in the department of regulatory relations or work on a temporary contract. This will give an opportunity to find out whether this work is to their liking and to get some small experience, which will certainly come in handy later. Another option that is popular in many companies for recent graduates is to start from the role of coordinator / assistant of the department, after a while moving to the position of a specialist.

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