Creating an Effective Regulatory Affairs Structure and Rockville Satellite Office

Behind every successful New Drug Application is an effective relationship involving representatives of the pharmaceutical industry and the U.S. Food and Drug Administration. Across the pharmaceutical industry, both small and large organizations place responsibility for oversight of FDA interactions within Regulatory Affairs.
This study examines what Regulatory Affairs organizational structure works best for interacting with the FDA and how the Regulatory function should lead interactions with the FDA. Additionally, this research explores how some organizations have found success in using a Rockville satellite office as a bridge to building lasting FDA relationships and providing insights on emerging regulatory issues.
Regulatory leaders can use the insights from this research to compare and adjust their group’s structure and how their Regulatory function leads FDA interactions.

KEY TOPICS

• Executive Summary
• Effective Organizational Structure for Regulatory Affairs
• Centralization of the Regulatory Function
• Role of Rockville Satellite Office

• Top Methods for Working with the FDA
• Organizational Oversight of FDA Interactions
• Does Regulatory Structure Mirror FDA Structure
• Organizational Structure for FDA Interactions
• Who Oversees Corporate FDA Interactions
• Importance of Washington/Rockville Office
• Top Three Activities for Washington/Rockville Office
• Importance Rating for Rockville Office Activities

• No benchmarked companies use a decentralized structure as this would hinder oversight of corporate FDA interactions. Nearly two-thirds of participating companies are highly centralized in how they oversee FDA interactions.
• A select group of companies that participated in this research see value in using the Rockville office to liaise with the FDA and to gather regulatory intelligence.

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