Theses (Master Of Pharmacy Practice)

Introduction: With the evolving regulatory landscape and economic importance to supply drug products to the market, the demand for regulatory affairs (RA) professionals is increased and it is imperative for them to be equipped with essential competencies to achieve effective performance. Observable skill gaps and talent shortage indicates that the inadequacies in education and training is partially responsible. The importance and usefulness of using adaptable global competency framework (CF) for local context is recognized worldwide for healthcare profession, however there is no study conducted to validate the feasibility in Malaysia. This study was conducted to identify the key competencies for the building of a CF and evaluate its relevance to support capacity building and career development in the RA professionals in the pharmaceutical industry. Methods: A mixed-method design comprised of sequential qualitative and quantitative phases was conducted. Participants were selected based on the inclusion and exclusion criteria. Semi-structured interviews to gather perspectives on the use of CF and key competencies whole cross-sectional survey to validate the competencies adapted from Regulatory Affairs Professionals Society (RAPS) regulatory CF. Qualitative data were thematically analysed, while quantitative data were analyzed descriptively using IBM-SPSS Version 23. Results: Three main overarching themes identified include the utilisation and implementation of CF with the associated benefits and challenges, key competencies required and the hiring challenges. High mean relevance were found for all domains, except for “scientific and health concepts” which remain debatable. Foundational competencies ranked higher in precedence as compared to functional competencies. iii Conclusions: RAPS regulatory CF is feasible to be used and refined for local adaptation. The findings can be used for developing a CF for foundation to intermediate level RA professionals from various background. It can also serve as guidance to identify and improve the level of performance and to address the training and education needs. Keywords: Competencies, Competency framework, regulatory affairs, mixed method, Malaysia, pharmaceutical industry, training, career development