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Grace Powers

Julie Watchorn

Regulatory Affairs Consultant, Parexel
Dublin, Ireland

RAC holder since 2017

 
 

How did you get into a regulatory career? What do you like about regulatory affairs?

As part of my master’s degree program, I took a module in regulatory affairs and also completed an internship in a global regulatory affairs department. These really opened my eyes to the opportunities in the area that I previously had little knowledge of. I enjoy the variety of the role and the constantly developing world of regulatory. No two days are the same and there is always something new to learn.
 

What is a typical day like for you?

Every day is completely different. I work on a variety of different projects for clients, typically writing clinical documents to support regulatory submissions, so my day generally revolves around whatever ongoing writing projects I have.
 

What motivated you to pursue the RAC certification? Does your organization encourage regulatory personnel to be certified?

My organization strongly encourages RAC certification. I wanted to strengthen my knowledge and prove my ability through certification—and I achieved that when I passed the RAC exam in 2017. Gaining the RAC has bolstered my regulatory knowledge and given me a stronger reputation in my department.
 

How did you prepare for the RAC exam? What steps would you recommend to someone thinking about achieving certification?

I spent lots of time studying RAPS’ “Fundamentals of EU Regulations” as well as guidelines from the European Medicines Agency (EMA). I used the RAPS checklists to ensure I had covered all topics and utilized some sample questions. For those who want to achieve the RAC, I would recommend creating and sticking to a study plan that works for you, to ensure you have ample time to prepare, and also to utilize the various RAC prep tools available.
 
 
 
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