Date of Conferral

2018

Degree

Doctor of Business Administration (D.B.A.)

School

Business Administration

Advisor

Gergana Velkova

Abstract

Pharmaceutical companies accrued fines of over $30 billion within 25 years because of noncompliance with regulations. Noncompliance with regulations results in fines and an adverse impact on company profitability. Some pharmaceutical company managers lack effective strategies to ensure overall company compliance with regulation. Based on complexity leadership theory, the purpose of this single case study was to explore strategies pharmaceutical company managers used to ensure compliance with regulatory requirements in Nigeria. The target population was functional managers purposely selected because they had successfully implemented strategies for compliance with the regulatory requirements in Nigeria. Data were collected through face-to-face and telephone interviews with 4 company managers and from company records, regulatory documents, and websites. Analysis of data involved using computer-assisted qualitative data analysis tools and content analysis to code and identify patterns and themes. Findings revealed 3 prominent themes: establishment of regulatory affairs unit and engaged leadership; hiring of qualified of employees, training, and continuous learning; and strategies to navigate through barriers to enhance regulatory compliance. The implications for positive social change lie in the availability of affordable pharmaceutical products with implications for the overall health of communities. Compliance with regulatory requirements helps to ensure that pharmaceutical companies develop high quality and safe products, which are critical in healthcare leading to the prevention and cure of diseases, which will ultimately improve and save people's lives.

 
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