From time to time I get questions from my colleagues and aspiring regulatory professionals about the benefits of the regulatory Master’s degree and Regulatory Affairs Certification (RAC), since I did them both. So, I decided to shortly address both of them hoping that you will find my observations helpful.
Regulatory Affairs Certification (RAC)
Certification can be a good mechanism for addressing a specific knowledge gaps since most of us work in a relatively specific and narrow regulatory field. Also, it could be useful in preparation for your career change and cooperation with the companies and colleagues from the different regions.
According to this report (1), 47% of surveyed regulatory affairs managers have Regulatory Affairs Certification (RAC) credentials.
I successfully obtained both RAC (EU) and RAC (US) credentials and they helped me develop a broader understanding of the regulatory requirements in these two regions and develop a holistic approach to typical regulatory questions, which in turn supported development of the skills and way of thinking needed for strategic positions.
RAC credentials are obtained via a computer-based examination. Each examination consists of 100 multiple-choice questions to be answered in a two-hour time period. Each examination presents a balanced mix of questions about product types, and those requiring critical thinking and analysis that can be applied to any healthcare product. Total costs related to the RAC examination are around 1,500 EUR (examination plus study materials).
RAC must be renewed every 3 years.
Also, it is important to mention that RAC holders on average earn 11% more in base salary than non-RAC colleagues (2).
Regulatory Affairs MSc
Master’s degree requires significant commitment and investment of time and effort.
I found it challenging but rewarding to juggle my daily activities at work and study for master’s degree, sometimes well into weekends. For example, the cost of obtaining a TOPRA MSc degree in regulatory affairs can be more than 25,000.00 EUR and up to five years in duration. Needless to say, any financial help from your employer in obtaining the credential is highly appreciated.
What is very convenient about this MSc is the logistics: attendance of the program is done through 8 “modules” which are actual professional courses lasting 2,5 days and are organized throughout Europe. This is extremely convenient if you are a busy Regulatory professional and cannot attend evening or weekend classes.
There are, of course, other graduate programs in Regulatory Affairs offered by various universities and offering various certificates. One example is the graduate program at the University of Bonn.
I did the TOPRA MSc, validated by the University of Wales. Was it worth it? I think it was, as I learned a lot in those 8 modules and while writing my dissertation. I met a lot of new colleagues who work across the world and created a global network of colleagues and friends who work for various companies and agencies.
Both RAC and Regulatory Affairs Master’s degree send a clear signal to your employee that you are committed to professional development and that you possess a strong critical thinking, ability and essential regulatory affairs knowledge.
Also, it helps in being recognized as a Regulatory Affairs professional and as a person to go to with your regulatory questions.
If you are thinking whether to get a RAC credential or MSc you need to consider:
How big your budget is? Who will pay, you or your employer?
How much time you have and what kind of schedule of studies you can afford?
What are your career goals?
If you have any specific questions about the RAC certification or the MSc program feel free to contact me.
1 RAPS, “Scope of practice & compensation report for the regulatory profession for 2016”, page 3
2 RAPS, “Scope of practice & compensation report for the regulatory profession for 2016”, page 19