Skills, Capabilities and Competencies for Success in Regulatory Affairs

The pharmaceutical industry uses Regulatory Affairs as its main communicator with the FDA. The success of a Regulatory Affairs group starts with hiring the right people. That’s not an easy task since a Regulatory Affairs professional requires an array of capabilities, from an understanding of basic science to possession of nimble negotiation skills. This study examines what is the most desirable skill set for a new Regulatory Affairs employee and the benefits/drawbacks of hiring former FDA officials. Regulatory leaders can use the insights from this research to compare their group’s skill sets and to consider whether to hire former FDAers.

KEY TOPICS

• Executive Summary
• Skill Sets
• Science versus Regulatory Experience
• FDA Experience
• Performance Measurement

• Top Methods for Working with the FDA
• Characteristics Most Important for Staff Working with FDA
• Ranking of Top Three Characteristics for Staff Working with FDA
• Backgrounds that Prove Most Effective for Interacting with FDA Reviewers
• Ranking of Top Three Backgrounds for Interacting with FDA Reviewers
• Number of Staff with Prior Work Experience at FDA

• Integrate multiple backgrounds and skill sets into Regulatory’s talent pool in order to build deep scientific, procedural, and agency knowledge.
• Selective hiring of well-connected FDA staffers helps seed insight, expertise and understanding of how the agency runs.

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