Competencies for regulatory affairs officers

Abstract

In the pharmaceutical industry, there is a constant need of personnel with the required competencies to handle tasks related to regulatory affairs. The aim of this study was to find the competencies required for pharmaceutical regulatory officers to succeed within the profession. The researcher also looked at the benefits of implementing these competencies into a post-graduate competency based educational framework. The study was carried out by conducting semi-structured interviews with 15 regulatory officers. The interviews consisted of 9 questions which were grouped into 4 sections; Demographic Data, Core Competencies, Role of Education & Future of Regulatory Affairs. The questions were validated via a focus group, followed by a second round of validation conducted via a 5 point Likert Scale questionnaire. The results of the interviews were used by the researcher to generate a list of 87 competencies. Seventy one of the competencies listed focused on technical skills. These were categorised into 5 groups by the researcher; European Pharmaceutical Framework, Regulatory Processes, Medical/ Pharmacy Knowledge, Quality & Batch Release and Pharmacovigilance. Sixteen of the competencies listed focused on managerial & organisational skills. All the competencies listed were validated via 5 point Likert Scale questionnaire. When asked which competencies are most difficult to adapt to; Regulation of Medical Devices (n=10), Compiling eCTD Folders (n=10) and Time management (n=9) were most frequently mentioned. Competencies relating to Centralisation of Product Registration and Submissions (n=9), Medical Devices (n=5) and Digitalisation (n=5) were mentioned when asked which competencies will increase in significance in the future. Fourteen out of 15 regulatory officers interviewed agreed that a competency based postgraduate academic coursework specialising in regulatory affairs should be offered by academic institutions. The researcher highlighted benefits of such an educational framework which included: benefits to employers who will find highly educated graduates to employ, benefits to students who will be equipped with the required competencies when starting their career, benefits to the academic institution due to high enrolment resulting from the growth of the pharmaceutical industry as well as benefits to the economy due to increased investment and job opportunities as a result of the highly educated workforce.