Apprenticeship case study

Amber McNair MTOPRA RSci, Clinical Trial Regulatory Manager, IVQIA

Amber explains why she applied to become a Registered Scientist and how it has helped move her career forward. 


Q: How did you get started in regulatory affairs?
I started my career as a forensic biologist with the Scottish Police Authority. Once I left, I joined a central lab as the anatomic pathology manager. I was the subject matter expert for companion diagnostic trials and we did quite a lot validation work and supported clinical trials. Then I made my shift over into regulatory affairs as a regulatory affairs officer three years ago, and I'm now in my current position at IVQIA as a clinical trial regulatory manager.

Q: What do you like about working in regulatory affairs?
I enjoy the fact that two days are never the same. We get involved in lots of different things such as submission processes, medical writing labels and consent forms. Clinical trials are so fast paced and you have to stay on top of the latest changes to the regulations and clinical trials and also in medical devices. 

Q: Why did you choose the Registered Scientist?
I chose to apply for Registered Scientist as I am still quite new to regulatory affairs, having only been doing it for three years. I think it's a great way for regulatory affairs professionals to demonstrate that there is a scientific link to whichever aspect of it that you're working in, as we are all still scientists by profession and at heart. Having this status demonstrates that I am committed to showing internal and external clients that I have a strong scientific aspect to my work. 

Q: What do you like most about being a Registered Scientist?
There is a real sense of personal achievement when you obtain your registration as a Registered Scientist. It's also a great thing to have to be able to show clients that that you are maintaining standards set by a professional body (the Science Council), and that you are committed to maintaining them through your continuous professional development. It also helps them to trust you more.

Q: How did you find the application process?
The information on the TOPRA website is very self-explanatory. The forms are very clear, and there are annotated ones as well. TOPRA even has an on-demand webinar that talks you through the application and shares how to prepare your supporting evidence. Throughout the process I didn't feel hesitant at all about reaching out to the professional development team to ask for guidance. It’s a very supportive environment and the process that they have in place is very easy to follow, which made the application much easier for me.

Q: What would you say to someone thinking about applying to become a Registered Scientist
If you are thinking of applying for Registered Scientist status, I would say go for it! It sounds like a scary process, and the application form does look quite long when you first look at it. But when you dive in, you find that there’s actually plenty of examples you can call on, particularly when you work in regulatory affairs.

There is a misconception that you have to work in a specific scientific field or have a science degree to have registered scientist, and it's really not the case. There are so many disciplines that will allow you to apply. So if you're thinking about it, you've already taken the first step. Just take the plunge and TOPRA will be there if you have any questions.


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