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Abstract

The role of regulatory affairs in the drug development process must and has expanded to meet the goals of quicker and more efficient drug development. The regulatory affairs professional participating in the process of development will be to a greater degree placed in the proverbial “hot seat” to achieve expedited clinical development and rapid review. To achieve this goal, the regulatory affairs professional needs to be proactive and futuristic in his/her thinking, be able to monitor regulatory trends, possess scientific expertise in one or more therapeutic areas, maintain constructive relations with regulatory authorities, work effectively with project teams, and develop an international perspective on drug development issues. This manuscript will explore these increasingly important issues and illustrate their application to various case studies of drug development.

Keywords

Regulatory affairs professional Regulatory trends International perspective Regulatory strategy

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The Regulatory Affairs Professional in the “Hot Seat” in the Drug Development Process

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