Regulatory Аffairs in the pharmaceutical industry – insights

• Published in: Macedonian pharmaceutical bulletin Vol. 66; no. 2; pp. 41 - 52
• Main Authors: Cvetanovski, Filip, Zareski, Rubin
• Format: Journal Article
• Language: English
• Published: 2021
• ISSN: 1409-8695; 1857-8969
• DOI: 10.33320/maced.pharm.bull.2020.66.02.005

The Regulatory Affairs as a field in the pharmaceutical industry has a lot of potential for individual professional growth. Formerly viewed as a clerical profession, growing requirements from competent authorities for a more regulated pharmaceutical industry resulted in growing interest and demand for regulatory proffessionals. The pharmacists working in a modern regulatory department unit are today viewed as key figures in obtaining the company’s goals and objectives. Their expertise can undoubtedly contribute to improving the strategy for the eventual market launch of a pharmaceutical product and provide for a better overall process in developing new products as well as maintaining ones that are already registered.
In this essay we delve inside the image surrounding this department, and try to bring forward what is actually behind it. We then look inside the organizational structure and everyday activities of a regulatory department, and offer our thoughts into making the processes in that department more efficient consulting the latest insights from leading experts on this subject.
Ultimately, we try to include the application of technological advancements into the picture and what their contribution would mean for managing information and thus an efficient way of functioning in such departments.
Keywords: Regulatory Affairs, technology, information, organization, efficient