Careerpath - Regulatory Consultant

Karin Ruijtenbeek

Karin van Ruijtenbeek

Job title: Regulatory Consultant
Company: Zwiers Consultancy
Highest level of education: PhD

As Regulatory Consultant, my main responsibility is advising on regulatory strategy and writing regulatory science-based documents. In our company the work depends on the client's requests. In my case I very often work on defining the regulatory strategy for medicinal products in early development, but I also do many writing tasks for preclinical and clinical parts of the dossier for a drug or device. Besides working on (regulatory) content, I coordinate and perform regulatory training programmes for people that want to start or extend a career in the field. Next to that I am also responsible for the corporate communication of our company.

What I like most about my work is learning every day! The regulatory field is very broad and our environment highly dynamic. As a consequence every assignment includes both aspects for which you can rely on your experience as well as those for which you need to get out of your comfort zone.
Regulatory consultants should be strong communicators: especially writing skills are important. And good team work makes daily working life easier and more pleasant.

How did you encounter previous regulatory job?
Networking. Alex Zwiers, CEO of our company, used to be my manager in my previous job.

Can you tell a little bit about the application process you went through?
Alex Zwiers asked me if I wanted to join the new company. I was doing a training in communication at that point in time. We came to the agreement that I could do the assignment to pass the training at Zwiers and in the meantime also perform regulatory tasks. The assignment was to set up the corporate communication for Zwiers.

What was challenging for you when you started in this position?
The change from Big Pharma employee to consultant in a smaller company

What are your tips for jobseekers in regulatory affairs?
In general, make a list of the companies you’re interested in and try to get in contact (even if they do not have any vacancies open), preferably via somebody in your network.
For regulatory:
• Make your CV regulatory-attractive. Find out what the most important competencies are and focus on those;
• Do not get put off too much by the “experience demands”. Even though companies may ask for 2-3 years’ experience, they may be willing to hire a talented person eager to learn;
• Take relevant courses and training (at Zwiers ;-)).


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