What kind of "affair" do you have with Regulatory?

I think for most people when we talk about "Regulatory affairs (RA)", there is an immediate eye roll and the thought is: boring job! I have to confess to you that before working professionally in the field, that was my reaction too... I thought it was an extremely static job, that would require me to be locked alone in a room reading all the laws and regulations. Luckily for me, I was terribly wrong.

My journey with Regulatory affairs stemmed from a common "friend," the Quality Assurance. In 2019, I was working with quality systems for medical devices in Brazil, and fate accidentally put me in touch with the HR department of a company for which I had submitted my resume to the talent pool (I did not believe this type of selection was real, but it is!). Even though I had zero experience in the field, the HR representative said my profile was extremely compatible. I went through the selection process and entered the field.

To my surprise, RA are NOT boring at all. On the contrary, it is one of the most dynamic jobs I have ever had in my life. But aside from this brief teaser of my personal story, today I wanted to talk to you about the type of relationship you, as a consumer of cosmetic products, have with regulation. Do you know what it is for? Do you understand its importance?

When you buy a cosmetic product, you trust that it is safe for your health, right? That you will be able to apply it with ease (of course, barring your personal allergies to ingredients, etc.). But in a nutshell, that is what sanitary regulation does for products that impact people's health, whether they are medicines, medical devices, cleaning products, or of course cosmetics.

The regulatory bodies responsible for each country or region are the regulators, and you have probably heard of several, such as the FDA for the United States, Health Canada for Canada, ANVISA for Brazil, and DG Sante for the European Union. Generally, these bodies are responsible for implementing regulations and also for overseeing and monitoring the development of all processes that allow the commercialization of a product that has an impact on health in a given region.

And here is where the Regulatory affairs folks come into the story. Basically, they bridge the gap between the company and the regulatory bodies we just talked about. The Regulatory affairs team basically ensures through technical documentation that the product met safety and labeling guidelines in the market where they were going to be sold. And that means compiling documentation related to raw materials, production processes, submission of notification/registration processes, and monitoring them throughout the product's lifecycle. But that is actually the pragmatic description of the job. What I can guarantee you is that the Regulatory affairs sector has a much broader and dynamic scope.

I emphasize this dynamism because the RA team is one of the few that is involved in practically every stage of product development, and consequently interfaces with numerous teams within the company. When the product is in its early stages, considering innovations in biotechnology, new materials, and so on, it is the Regulatory affairs team that can analyze R&D inputs and say how it is possible to continue development while ensuring compliance with the regulation. For example, it is pointless for R&D to bring a revolutionary nanocapsule to a product if it does not meet the requirements of current legislation, and in the case of Europe, we do have very specific regulations for nanocosmetics.

Then, the RA team continues to lead and support safety assessments, clinical trials, efficacy testing, and risk management. RA also plays a very important role with packaging and labelling, advertising and marketing. Towards the end of the timeline, RA compiles all the documents, write the dossiers, submit to the regulatory agencies, monitors the process and maintains all records, also helping the Quality Assurance team to keep everything that is necessary for relevant certifications and audits.

In addition to the hard work within projects, Regulatory affairs experts also monitor the latest trends and regulations around sustainability, green chemistry, standard certifications, and ethical trade. The cherry on top of the profession is that there are not as many professionals available with the profile for this work that requires excellence in technical knowledge as well as communication skills, and that is why regulatory affairs professionals are often in high demand and well compensated for the work they do.

In conclusion, the world of regulatory affairs is far from being a "boring job". It plays a crucial role in ensuring the safety and efficacy of cosmetic products, along with various other health-related items. As consumers, understanding the importance of RA can empower us to make informed choices about the products we use daily, so our "affair" with it goes beyond mere compliance; it is about ensuring that the products we trust are not only effective but also safe for our well-being. So, next time you pick up your favorite cosmetic, remember the intricate dance of Regulatory affairs behind its formulation, and appreciate the efforts that go into making it a reliable part of your beauty routine.