Abstract

The most critical skills for advancing in regulatory affairs are rarely taught. Regulatory professionals operate at a complex interface between industry, regulators, healthcare professionals and patients. While technical expertise remains essential, effective performance increasingly demands capabilities that extend well beyond scientific and regulatory knowledge.

Drawing on in-depth interviews with a panel of experienced regulatory professionals across Europe, the UK, Switzerland and the US, this article identifies the non-technical competencies most strongly associated with career advancement: negotiation, communication and influence, strategic thinking, creativity in regulatory strategy design, and the ability to manage complex cross-functional relationships. Critically, respondents reported acquiring these skills primarily through trial and error, and often in high-stakes situations without structured support. The article argues that this gap limits both individual progression and organisational effectiveness, and proposes a rethink of the approach to developing regulatory leadership excellence.