Regulatory Affairs (RA) for a pharmaceutical or medical device organisation are responsible for obtaining licencing approval for new products and ensuring that approval is maintained for as long as the product is on the market. It encompasses all of the regulatory protocols surrounding the development, efficacy testing and procedural compliance as well as communication between company and licencing organisations.
I caught up with Kejsi to ask her view on skills in Reg Affairs as she is someone who is starting out in her career and therefore perhaps isn’t so removed that others can’t see the pathway and appeal of her journey, should they decide Regulatory Affairs is the career for them.
Kejsi started her role at the beginning of May. It is her first role within this sector of industry for a global healthcare pharmaceutical corporation that CY Partners work with. She first learnt about Reg Affairs however 4-5 years earlier whilst doing an MSc in Pharmacy. There were modules on pharmacology highlighting how drugs were developed and tested and how they got to market. During the Covid-19 pandemic Kejsi simultaneously studied on her thesis and worked full-time as a dispenser in community pharmacy, the other end of the drug to patient pathway. “Working in Regulatory Affairs feels like I am contributing and being more involved at the beginning of the process”
“I am under-going a massive learning curve at the moment, having had training and then being an assistant to someone on a project for a mature product under EU regulations that works on anxiety and depression, I am just starting to do my own thing, and to be responsible for my own actions; it is a project that is running until January 2022 on the renewal of a license for a medicine which helps ease breathing problems and is used as part of a plan to manage asthma.”
“Having worked in Pharmacy as a dispenser I was already aware of how important attention to detail is and mistakes in that setting can be harmful. Within Reg Affairs, attention to detail is just as important”.
“Speak up. Don’t shy away from communicating as you can’t learn and understand this on your own. I have a good manager who I am speaking to daily to ask questions and I learn as I go. There are also meetings and teams across the world that we need to communicate well with”.
“Meeting deadlines, obtaining files from the correct systems in good time. Even training needs to be submitted on time for security reasons and so I don’t put anything off until tomorrow”.
“So much. You can really see rewards for your effort, with progression opportunities and new projects coming in. I won’t get bored and I learn so much. I never stop learning. It’s like I will be graduating from ‘Company X’ at the end of my journey!”
There are lots of different ways to get into regulatory affairs; whether you are in QA and want to move across or have been in the laboratory and would like to explore the legislative side of getting a drug or medical device to market. Having a background in science is fantastic as you will already know the building blocks. So make sure you emphasise the above 3 skills in your CV as well as think of examples where you have demonstrated them, that you can talk about at interview. I look forward to catching up with Kejsi again soon to see how she is getting on.