Last month, a record number of RAPS members and guests gathered at RAPS headquarters for a RAPS DC/Baltimore Chapter event to hear Linda Bowen, head of US regulatory policy and intelligence at Sanofi, speak on the role regulatory intelligence plays in today’s highly regulated environment. Attendees came from throughout the Mid-Atlantic region, including Delaware, DC, Maryland and Virginia, to hear Bowen’s expert advice.
Bowen discussed various definitions of regulatory intelligence and explained that, essentially, it is the act of gathering and analyzing publicly available information. This includes monitoring the current regulatory environment for opportunities to shape future policy, legislation, regulation and guidance, as well as communicating the implications of gathered information.
She stressed that regulatory intelligence does not include gathering and analyzing competitive intelligence, propriety information, sales and marketing information, drug pricing or insurance information, or information on reimbursement issues. She explained that, in general, most large and some medium-sized companies have a dedicated regulatory intelligence function, and in those companies the function acts as a partner and respected resource in the search for regulatory information and precedent, and in the development of actionable regulatory intelligence. On the other hand, many small companies lack the capacity for a dedicated regulatory intelligence function.
Bowen advised that anyone who aspires to work in regulatory intelligence should have five or more years of regulatory experience, a scientific background, the ability to think analytically, excellent communication and presentations skills, and she said it wouldn’t hurt to be something of a “true detective.”
In addition, a regulatory intelligence professional needs to develop good networking skills and should be able to cultivate productive relationships with fellow staff members and peers in trade and professional organizations like RAPS.
Those who want more information about the regulatory intelligence function may want to attend Mid-Stage Regulatory Career Paths – Tips, Tools, and Discussion, 27 October, 3:45–5:15 and Handling Regulatory Challenges: How to Respond with Grace Under Pressure, 28 October, 8:30–10:00 at RAPS’ Regulatory Convergence where Bowen will be a speaker.