It appeared very interesting to me on the first lecture that positions in regulatory is in demand. Just want to ask for insights from those who are in it or know more information: how do you actually start a career as a regulatory affairs position, especially with the background of being in the lab and doing research? is there a certificate needed? Coursework requirement at all? Or just try my best to look and apply for a fresher position and get trained? I believe there will be a lot of writing, would it get boring if you're writing to fulfill certain requirement again and again for different products?
From what I gathered from our week 4 lecture video, it appears that a lot of people in regulatory affairs actually come from a research or lab background, which allows them to understand the science/technicalities behind their work. In my opinion (gathered through my intense online job searches) most entry-level regulatory jobs don’t require a certificate to start and many companies are aware that as a new graduate you might not have all the knowledge, but as long as you're willing to learn they will train you on the specific regulations and submission processes. However, if regulatory affairs is something you know you definitely want to pursue as your lifelong career, then it might be best to look into getting that certification or even a master's degree in that area. This not only helps you stand out but shows your commitment to the work.
As for the work itself, I am not very knowledgeable, but from the conversations that I had with a colleague (who worked in the regulatory affairs department) during my internship, they expressed that the position required a lot of writing, and not the creative kind. The writing mainly consisted of regulatory submissions, summaries of preclinical/clinical data, and responses to agencies. It can get repetitive at times, especially if the company specializes in a specific kind of drug or medical device, but if you're someone who enjoys documentation and organization, then this is definitely the job for you.
If you're looking for ways to get your foot in the door, I would recommend looking for associate regulatory affairs positions or even QA/clinical documentation roles. That way, you’ll be able to pick up specialized knowledge and use your lab background to help you further understand the science behind what you're writing and guidelines you're looking for.
I've also been interested in regulatory affairs since this class started, especially because Professor Simon keeps mentioning how it's a growing field with a lot of job opportunities. What I keep wondering, though, is whether there is any creative aspect to it especially when working with engineers. For example, if regulatory specialists are involved in the early design process, do they get to help shape how a product is developed so it meets requirements from the start? That feels like it could be more collaborative and creative, rather than just repetitive writing. I'd be curious to know from people who've working in regulatory, does the job feel more like routine documentation, or are there opportunities to problem solve and innovate when working alongside engineers and design teams?
