In the second year of my Biological Sciences degree, I decided I wanted to do a placement. I immediately started looking for jobs in laboratories. I imagined myself working in research, lab coat on, spending my days looking down a microscope. The placement I secured was in fact very different. After quite a few applications, and a disproportionate number of rejections, in 2018, I began my Industrial Placement Year with Johnson & Johnson in Regulatory Affairs. This experience opened my eyes to the variety of careers available in the pharmaceutical sector, changing my perception on what it means to be a “Scientist”.
What is Regulatory Affairs?
You may have heard Regulators and Regulations thrown around by the media when talking about the new COVID-19 vaccines. As a Regulatory Affairs professional, it is our job to ensure medicinal products meet the legal requirements (regulations) of the country. Before a medicinal product can be launched for sale on the market, it must pass a series of checks to ensure it is safe, effective and of a high quality. These checks take the form of Clinical and Non-Clinical studies, including Clinical Trials, where the medicine is tested in humans in three phases. Once the evidence has been collected, it can be submitted to the local health authority, in our case the Medicines and Health Products Regulatory Authority (MHRA), for approval. Regulations are essentially a protective force between medicines and the public. They provide guidance to be followed to ensure medication is “safe” for the consumer to use. I use “safe” in adverted commas because all medicines have side-effects, but not everyone gets them. Therefore, the safety is assessed through the benefit vs risk, i.e. does the treatment the medicine provides outweigh the risk of potential side effects.
Industrial Placement at Johnson & Johnson
When I worked at Johnson & Johnson, I was mainly responsible for the global maintenance of Medical Device licences. Medical Devices achieve their action by physical means, not pharmacological effects, like a traditional medicine (drug) would. They include products like knee implants, tools used in surgery and diagnostics. They also extend other products, for example, a face cream for rosacea that acts as a “protective barrier complex” to prevent flair ups.
All medicines and medical devices need a licence to be sold, as they indicate the product meets the regulations. To achieve this licence the company will submit a “dossier” to the relevant health authority. The dossier is a collection of all the documents that demonstrate the product is safe, effective and of high quality. To maintain this licence, various documents need to be updated and resubmitted to health authorities, as new data about the medicine is collected. Johnson & Johnson is a global company, many of their products were marketed and sold in various different countries. This meant I had to collate and send these documents globally. I was speaking to people all over the world, from Saudi Arabia, to Montenegro, to Malaysia. It was incredible speaking to people from countries I’d only ever seen on a map. I was surprised at the connections I formed with colleagues from only speaking to them on the phone. I worked closely with a colleague based in Boston (USA) and when I left the company we exchanged emails. I promised I would come visit her next time I flew to the US to see family.
Day-to-day work as a Regulatory Affairs Consultant
Now I’ve moved to a consultancy company, the work is more varied. We have many different clients come to us with different products and needs. Aside from Medicines and Medical devices, we also work across Food Supplements, Cosmetics, Borderline and General products. These products have different regulations and importantly cannot make medicinal claims, that is, claims stating they treat or prevent disease.
So far, I’ve worked on several medicine “post-approval” projects. “Post-approval” refers to the process after the medicine is approved and placed on the market. The work doesn’t stop when the product has been launched and is being sold, clinical data still needs to be collected to confirm the risk of side-effects (called adverse events). It is the responsibility of Pharmacovigilance to collect this data, anything they spot may need to be added to the medicine’s information, particularly that supplied to the patient or healthcare practitioner. It is a Regulatory Affairs Officer’s job to submit this information, as a variation to the licence. I have also done several packaging reviews for Food Supplements, checking their claims are compliant, along with the ingredients and any images on pack.
As for day-to-day tasks, our role is very dynamic and reactive. Emails come in from clients with various different questions, we then refer to our own knowledge and the regulations to answer them. Sometimes these questions will ask about a “grey area” in regulations, i.e., where there is not really any specific guidance. These are the most exciting, because the way we interpret the regulation, and the response of the client, will shape the product and healthcare industry’s future.
I was lucky enough to enjoy Regulatory Affairs from the get-go, however even if I hadn’t, doing a placement in Regulatory Affairs would have still been beneficial. It taught me to look outside of the lab for future careers. When at University, I felt as though the only options were the labs or teaching. Although I could see myself working in both those roles quite happily, I couldn’t help but think there was something else out there that would speak to me more. Fast forward to now, I’m incredibly happy and grateful to be a Regulatory Affairs Officer, but more than that, I’m creating a career that fits me. Part of this venture is my blog theScienceGrad. As many placements and internships have been cancelled this year, I imagine it is incredibly tough for those looking for experience. My advice would be to get on LinkedIn, and connect with people in the industries you’re interested in. Send them a message and ask to chat about their job, you will be surprised at how many people are willing to help.
For more from me, and if you have any questions about Regulatory Affairs, follow and message me on Instagram or LinkedIn @thesciencegrad.
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