Written by: Michelle Schoenmakers
Regulatory affairs (RA) and regulatory submissions (RS) - you might even come across other names as well - are different names for an overall discipline, usually found in the pharmaceutical industry. In each company, the responsibilities and tasks of people working in RA/RS may vary. This is why most people do not have a clear view of what RA/RS actually entails. I have previously worked as an RA officer for a consulting company lending services to pharmaceutical companies in developed products, such as medicines and medical devices. Now, I work as an RS coordinator for a Contract Research Organisation (CRO). A CRO provides services to pharmaceutical companies during the development - and thereby research - stage of medicines and medical devices amongst others. Based on my experience in this field, this article will give you a more clear view on RA/RS and when this might be a suitable job for you.
First of all, why is the word “regulatory” part of the definition of the discipline? That is because in these positions associates are making sure that certain regulations, set by regulatory authorities, are followed. Examples of such regulatory authorities are the European Medicine Agency (EMA) and the Federal Drug Administration (FDA, United States). These authorities assess whether regulations are followed and must grant approval before the pharmaceutical companies can either perform research studies or market a safe and effective product.
As mentioned before, my experience stretches from developing products to already developed products. When we look at developing products, this is essentially performing (clinical) research to find out whether a (medicinal) product is safe and effective. In order for a company to be allowed to perform research on a product, approval must be requested from the regulatory authority. A research file will be submitted to a regulatory authority, as well as an ethics committee, to request this approval. The file includes information about the product and the research study. If the regulatory authority does not approve the study initially, additional information might be requested from the applicant. This will then be submitted again and be assessed by the authority. When the authority (and ethics committee) eventually approves, the study may be started. However, if you are thinking your work as RA/RS associate stops here, you are wrong. While the study is running, there might be changes to for example the study protocol or other study documents. Changes to the study must be approved by the authorities as well, so you will amend the initial research file and submit the changes to the authorities. Again, questions might be received which must be answered before the changes are approved.
When we look at developed products, the cycle is approximately the same. When a product has been proved to be safe and effective in clinical studies, a pharmaceutical company will mostly try to register the product in multiple countries. Products can only be marketed when they are registered. Similarly to the research studies, the RA/RS associate will compile a dossier in which information about the product is collected, such as how it is manufactured and how it is checked to be safe. This will be submitted to regulatory authorities and multiple question-response rounds might take place. After initial approval, the product may be marketed in the concerned country. But guess what… there might be changes to the approved dossier, such as a change in the manufacturer’s information. Again, the RA/RS associate will prepare and submit the changes and make sure that these are approved.
Now that you have gained more insight in the RA/RS tasks, it might not surprise you that these jobs are mainly performed behind a computer at a desk. However, the content of tasks vary a lot and you are constantly in contact with colleagues, as well as with authorities from time to time. Also, don’t be worried if you don’t have a background in law for example. The regulations to be followed are really specific to medicinal products/medical devices, so you don’t have to know certain laws by heart. If this sounds like something that might be up your alley, don’t be scared off by lengthy and elaborate job descriptions!