In Focus: Regulatory Leadership

Posted 01 September 2008 | By

Years ago, I attended a RAPS conference that featured an interactive session on product development. Speakers took on the roles of the management team and presented the product strategy to the "investors" (the audience). One person played the role of the CEO; others took on the roles of the CFO, the VP of development, the VP of marketing and so on. After all the members of the management team had spoken, the CEO said, "Oh, I should introduce our regulatory person. Now, where is he, and what is his name?" There was laughter in the room, but most of the audience related to the situation. Regulatory often was considered the "gatekeeper" department, holding up the marketing of the product until the right forms were submitted to FDA.

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