The Widening Talent Gap in Regulatory Affairs is a Problem for Small Pharma

The Widening Talent Gap in Regulatory Affairs is a Problem for Small Pharma

In sports, payroll tends to have a big impact on the quality of a roster. Though it doesn’t always equate to Stanley Cups or World Series rings, the rule is pretty simple: more money equals better players equals more wins.

In pharmaceutical regulatory affairs, the same is increasingly true. To the detriment of smaller players and the benefit of bigger ones, talented regulatory affairs personnel are in high demand; this seems to be driving rapidly growing salaries. Companies with deeper pockets are snatching up the best and brightest regulatory affairs professionals working, creating a talent gap in the industry, the ripple effects of which are numerous and consequential.

Among the staffing and budget data for our latest report, “Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy,” we saw some new trends taking hold in the regulatory landscape. In one of the most intriguing findings, survey respondents reported that among most large- and medium-sized companies, submission timelines are either static or getting shorter. Just 27% of surveyed companies thought that timelines are getting longer. Compare that to small companies, where 69% thought that timelines are getting longer.

How the timeline for regulatory submission has changed for small and large companies (click for detail)

The FDA in particular has ushered in accelerated timelines and shorter submission evaluation windows, meaning that companies should be experiencing expedited review times in the U.S. But the data above clearly indicates that is not the experience of smaller companies. Large companies with experienced personnel and long-standing relationships with regulatory agencies are in position to leverage those relationships toward expedited review times. This is in contrast with smaller and often less tenured staff at smaller companies. Most of these companies are comparatively new to the regulatory playing field, have not built deep relationships with regulatory agency personnel, and thus do not have a direct and familiar point of contact when problems come up.

Many surveyed companies reported increasingly stringent experience requirements for new hires. Nowhere is the benefit of experience more evident than when dealing directly with regulatory agencies. While many smaller companies’ contact with the FDA is mostly limited to written correspondence, large companies with deep experience on their teams report more direct and more frequent communication with the FDA. All of this illustrates those ripple effects mentioned earlier. The most well-networked and connected faces in the regulatory field appear to be consolidating at Big Pharma companies, leading to improved regulatory processes and submission outcomes. The flip side is that smaller players are having a harder time keeping up with the fast-rising salaries that top regulatory affairs specialists can command. Companies that have to create these key connections from scratch suffer process delays and worsened regulatory outcomes.

For smaller companies, larger budgets and additional staffing for Regulatory Affairs have not yet delivered on earlier hopes. Meanwhile, at larger companies, the focus is more about allocating budget to keep key personnel in place. That is, budgets are growing because it costs more and more to retain existing (or recruit new) regulatory affairs stars. There’s no collective bargaining agreement, salary cap, revenue sharing, or parity initiatives. The big-market teams can offer big money, big exposure and big projects. In many prospects’eyes, small-market teams have to scrap for a share of the regulatory affairs talent pool.

Companies that find themselves falling behind their larger competitors in regulatory submission effectiveness need a game plan to level the playing field. Whether that plan focuses on the draft (identifying, developing and retaining individuals with the most potential) or free agency (the willingness to marshal resources and create competitive salaries for the most influential specialists), regulatory affairs teams need to get their playbook in order and execute as quickly as possible.