Dr Jan Sjöberg, Medical Advisor and NDA Advisory Board Member, started his career with little knowledge about what being a pharmaceutical regulator means. Driven by curiosity, he took on the challenge of discovering this unfamiliar territory.

Jan started his medical studies in 1984, specializing in internal medicine and haematology at the esteemed Karolinska Hospital and Institutet. He later became the head of the haematology clinical trial unit at Karolinska and held the position for more than six years.

Jan's path to regulatory affairs was unplanned and marked by a chance encounter. According to him, a roommate showed him a job advert in a newspaper for a position at the Swedish Medical Products Agency (MPA). His initial perception about the role of a pharmaceutical regulator was an officer who outrightly approves or rejects a proposal for new medicines. But this perception soon evolved as he discovered that regulatory affairs was far beyond his initial assumptions.

“I thought my role at the Swedish Medical Products Agency would mostly require looking at the clinical trials and saying no with a big stamp but that was not the case. When I joined the MPA, I was involved in providing national scientific advice for pharmaceutical companies and meeting with the people behind the regulatory proposals. This made me appreciate the role of a regulator and understand the level of research that comes with such role.”

When Jan joined the MPA in 2010, his primary focus was on oncology and haematology products. Additionally, he held various roles that involved clinical assessment and leadership in quality assurance.

“I was a member of the agency's internal Quality Assurance Group where I contributed to different areas of quality control. As a group, we worked to make sure that quality standards were maintained throughout the regulatory process.”

Jan actively participated in the Scientific Advice Working Party (SAWP) for many years, dedicating his time to providing valuable insights and collaborating with colleagues on projects. In 2020, Jan joined the Icelandic Medicines Agency. “My role at the Icelandic Medicines Agency involved international collaborations, focusing on SAWP matters and the scientific evaluation of medical products. As an alternate member for the CHMP in Iceland, I represented the agency in regulatory matters,” Jan said.

Jan later joined NDA as a Medical Advisor and Advisory Board member, where he provides medical advice to clients with an unbiased and client-focused approach. Whether he is working as a regulator or medical advisor, he is passionate about empowering clients to develop medicines that can potentially transform lives. Jan explained:

“I enjoy interacting with clients and try my best to provide solutions to their unique needs. Working with different types of clients and different projects at NDA has helped expand my knowledge and understanding of how to guide clients through the different stages of drug development.”

Jan enjoys his role at NDA because of the collaborative work environment and meaningful client interactions. He said:

“I am inspired by the professional approach and expertise of my colleagues at NDA, and I am constantly learning from them. They show teamwork and support when we work together on projects, and this creates a positive environment for everyone to contribute.”

Jan brings in his extensive experience as an ex-regulator to assist NDA clients through the processes of drug development. He draws some similarities between his roles as a regulator and medical advisor, explaining that both roles involve understanding scientific details and ensuring that drug development aligns with regulatory requirements. “I believe I am doing almost the same job now as I did when I was a regulator. For me, the role of a medical advisor is to support drug developers bringing promising drugs to and through regulatory evaluation and ultimately making the ones with a favourable benefit-risk balance accessible to patients,” Jan commented.

In Jan's perspective, the impact of regulatory affairs extends beyond paperwork and compliance—it is about making a tangible difference for the client. By facilitating a smooth interaction between science and regulations, regulatory affairs experts help drug developers to understand the regulatory requirements for bringing innovative medicines to patients. In Jan’s words:

“Regulatory affairs is the interaction between scientific knowledge and regulatory requirements in drug development. Working at NDA, I can still make a difference for the drug developers by supporting them through the EU and US requirements, ensuring a seamless process and adherence to regulatory standards.”