Regulatory Affaris Diploma 

Why you should do it, and what will get you through

February 2019

Do You Consider Taking the Regulatory Affairs Diploma?

Committing to eight courses in a row can seem overwhelming. You’ve probably got enough on your plate already – work, family, friends, exercise … And to be honest, it is a stretch, but here is why you should do it anyway and what will get you through.

We have interviewed two of our “old” students. Professionals within the field of Regulatory Affairs who worked their way through the exams to the diploma and now benefit from the knowledge it gave them.

In summary, this is their advice: 

Why you should do it  
(because yes, they really think you should):

  • Important knowledge that you can apply directly
  • Relevant course material you can draw upon moving forward
  • Improved job satisfaction by having the “big picture”
  • Relevant for your career and future career moves


What will get you through  (because, yes, it’s tough, but you can do it):

  • Make sure to have some experience from the field before your start
  • Involve the people close to you – you will need time to study
  • Plan wisely – two modules or three at the very most each year

Bettina Lindharth Madsen, Principal Regulatory Affairs Professional at ALK Abelló A/S and Anders Gerner Petersen, Head of Regulatory Affairs at Merck Group both completed their RA-diploma almost 10 years ago. That is why they can now look back and with confidence say it has made an impact.

“For me, being new in the field back then, picking up new knowledge and getting the “big picture” had a very positive impact on my job satisfaction. Over the years it has been an important asset in my career moves and definitely helped me pursue my job aspirations,” Anders tells.

“The knowledge from the courses has on top of my daily on-the-job learning, helped me develop skills and competences easier and quicker and thereby created new opportunities in my carrier,” Bettina supplies. 


Set aside time

Even if both Bettina and Anders recall long hours buried in books they would do it again without a doubt. Their advice is to have some practical experience to make the theory relatable and for each module to carve out a couple of weekends for uninterrupted studying. They both agree that two modules per year is manageable.

Bettina recalls the gift of practical experience: “I cannot stress enough how much it meant for me that I already had a few years’ experience when I started. I could relate more easily to the theory and I could apply it directly in my daily work,” Bettina explains.

Having small kids at the time, Anders made sure to have his wife’s support: “What worked for us was taking time away. Each module I allocated a couple of weekends and took time away from the family,” Anders remembers.



Our diploma in Regulatory Affairs provides you with up-to-date, in-depth knowledge of the most important theoretical and practical aspects of regulatory issues related to pharmaceutical and biopharmaceutical products. You will gain an understanding of the entire ‘regulatory affairs cycle’ from molecule to marketing authorization and maintenance.


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Find More inspiration in these articles: 


When things change at such fast pace that keeping up can seem impossible, it is important to find pragmatic and manageable shortcuts to relevant and timely input and feedback. We have interviewed one of our course participants about how he manages to stay on top. Meet Anders



Your professional needs differ over time, depending on your career path and your life situation. Meet Bettina Lindharth Madsen, Principal Regulatory Affairs Professional at ALK Abelló A/S, and learn how her commitment to lifelong learning has unfolded during her career. Meet Bettina