Exploration of the Training/Educational Background and The Roles of Regulatory Affairs Associates/Officers in selected South African Based Pharmaceutical Companies in Gauteng Province
Regulatory Affairs (RA), within the pharmaceutical business, could be a profession that covers completely different registration parameters of a pharmaceutical product. This is often a replacement profession that was developed to shield public health by providing the smart quality pharmaceutical product as well as safety and efficacy. The study aimed to explore the coaching and role of RA associates/officers in pharmaceutical corporations in Gauteng, South Africa. The study was a cross-sectional survey, which utilized google forms with both open and closed-ended questions. Using descriptive statistics, it was found that, majority of the participants (78.3%) (RA assistants, officers, and scientists) indicated that most of the responsibilities they carry out were through informal training (i.e. learning on the job). However, even though various pharmaceutical companies have different titles for this personnel, it was observed that most of them perform almost the same functions (i.e. Prepare submissions of license variations and renewals to strict deadlines, with 91.3% of the participants learning the skills on the job). Furthermore, it was recorded that most RA personnel have experience of between 1-5 years (56.6 %) and that most RA personnel acquired their job through an internship (43.5%) and external vacancy (43.5%). Moreover, it was also observed that most RA personnel (43.5%) have more than one qualification (Honours Degree and MSc Degree). Although specialized training is required for RA personnel, only 30.4% of the participants were trained to provide strategic advice to senior management throughout the development of a new product. About 13.0% of the participants were trained to plan and develop product trials and interpret trial data.