Abstract

Regulatory affairs professionals have an important role to play in the arduous journey of developing and bringing a veterinary medicinal product onto the market. They have significant input into strategic decision-making in the early drug development phase, which continues through the testing phase when the data for a marketing authorisation is generated in a stepwise manner. They continue to be engaged throughout the marketing authorisation process, from the pre-submission phase through application and approval, until eventually the product is licenced and can be marketed. Their work does not stop here, as throughout post-authorisation, regulatory affairs input continues when extending or varying the marketing authorisation and maintaining the up-to-date application dossier.

The regulatory affairs professional has a multidisciplinary role. In addition to the required technical and scientific knowledge, strong communication within and outside the organisation is essential, and efficient planning and project management skills are important at all stages. The role also enables continuous learning and the development of new skills, promoting growth in the role over time.

This article provides an insight into the career of a regulatory professional in the veterinary sector for those looking to enter the industry, and discusses the personal and professional requirements necessary to succeed in this role.