Job title: Consultant Regulatory Affairs
Company: ProPharma Group
Time in this position: started 6 months ago as Associated Consultant Regulatory Affairs
Highest level of education: PhD at department of Pathology, AMC (and 6 years of postdoc experience)
ProPharma Group partners Life Science companies to solve their complex challenges. Various services are provided including support of (bio)pharmaceutical facilities (engineering & technology), qualification and validation of systems, clinical and post-marketing pharmacovigilance surveillance, and writing of scientific and regulatory documents. I am part of the regulatory affairs department. Together with colleagues, I support the client with writing part of the marketing authorization application. I like to compile a document based on different source documents and discussions with the stakeholders. Besides, it is very interesting to dive into all the regulations and guidelines that are there to warrant the quality, safety and efficacy of medicinal products. This is done during writing, but also when a client has a specific question and you need to know how for instance, the European authorities look at this. Another part of my work that I enjoy is reviewing documents to improve the quality of e.g. a marketing authorization application by checking for instance all cross-references to make sure that the dossier is consistent and that the conclusions are scientifically sound.
How did you encounter this job?
After my academic career, I knew I wanted to pursue a career in regulatory affairs. I was looking for consultancy companies because I like to work in a dynamic environment where you have the opportunity to work on various projects together with experienced colleagues giving you the chance to learn. Searching the internet I found ProPharma Group and was attracted by the way they present the company and the clients they work for. This made me apply for a job at ProPharma Group.
Can you tell a little bit about the application process you went through?
I applied to an open position and after a phone call with the recruiter, I was invited for a first interview face to face. Within three 3 weeks I had a second interview and a week later I got a job offer.
What was challenging for you when you started in this position?
Without a background in regulations, the big challenge was to get insight into the field of regulatory affairs. A practical example is getting familiar with abbreviations and other jargon.
What are your tips for job seekers?
If you want to change field, use your network to find out more about other jobs and companies. Follow a course or attend meetings to show employers that you are really interested in this other field. And if you apply for a job, follow-up your application/interview.
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