Case study

Regulatory intelligence and policy manager — João

João is passionate about his work and is keen to make a difference in the development of medicines, which will ultimately improve patients' health

After graduating with a degree in pharmacy, I worked in two professional roles before getting my current job with an international pharmaceutical company.

The key skills I developed through my degree were the ability to create value in various teams and to interpret the impact of information and data in health outcomes and, ultimately, public health. My degree was very important as it gave me the scientific as well as the human background to understand that any field of work in the pharmaceutical industry ultimately exists to improve patients' health.

I was very keen to understand the steps related to drug development and, specifically, what kind of judgement is needed to approve an innovative medicine. I started exploring this path in a generics company, a small affiliate where I could work closely in areas related to drug safety, scientific assistance and regulatory support.

However, since I believed that to understand the regulation of pharmaceuticals you should learn from an organisation that actually regulates, I applied for a traineeship with the European Medicines Agency, which I got. The Agency is responsible for evaluating a great number of medicines targeting serious conditions such as cancer or neurodegenerative diseases in the EU. This traineeship provided me with a valuable insight into how medicines are actually evaluated and how important that regulation is for the assurance of public health.

After the traineeship, I wanted to put into practice all I had learnt, especially in a company that develops innovative medicines for unmet medical needs. I got an interview for a position as a regulatory intelligence and policy manager with a big pharmaceutical company and ended up getting it.

My main function is to monitor important regulatory developments (for example, the publication of new guidelines) and to evaluate their impact for our drug development. I also provide support to more experienced regulatory strategy colleagues on deciding how to develop our strategy with the greatest impact for those who will take our medicines.

On a day-to-day basis, I liaise with colleagues from different departments and I am in contact with many sources of information to ensure the company is up to date with its knowledge about the regulatory environment in order to successfully approve innovative medicines. I participate in teleconferences with project teams and other colleagues most days, while I use some of the time to read guidelines, literature and other sources that allow me to make a better impact analysis. In addition, I also contribute to professional societies such as The Organisation for Professionals in Regulatory Affairs (TOPRA), which has been key to my professional path so far.

My role is challenging and complex as I need to have a good understanding of the regulations and laws governing medicines. However, I'm also passionate about it due to the variety of information and knowledge we are in contact with. Using that information in my daily work helps me to master certain topics I'm particularly interested in.

In the future, I would like to keep using this role to become even more competent as a drug development professional and to really make a difference in the development of medicines for unmet medical needs.