Regulatory Focus™ > News Articles > Survey of Regulatory Pros Draws Increasingly Global Response

Survey of Regulatory Pros Draws Increasingly Global Response

Posted 19 March 2014 | By Zachary Brousseau 

RAPS' biennial research survey of the regulatory profession, launched at the end of January and continuing through Monday, 31 March, has garnered well over 2,000 responses to date, with 29% from outside the US. The Global Scope of Practice & Compensation Survey has been conducted by RAPS for nearly 25 years, and it continues to be the largest, most comprehensive study of the healthcare products regulatory profession.

Increasingly, survey responses are coming from professionals working all over the world. While the majority of respondents are US-based, response from outside the US has grown from 17% in 2008 to 19% in 2010 up to 29% for the most recent completed survey in 2012. This year's survey currently matches that, and includes respondents from at least 53 countries.

Two Weeks Left to Complete Survey

RAPS' leaders are hoping to garner more than 1,000 additional responses over the survey's final two weeks, to maintain or surpass the previous survey's global representation. A report highlighting the results will be published in June. The highly anticipated report provides the best known data on what regulatory professionals earn, what they do and who they are demographically. In addition, the survey results provide insight into their career paths and motivations.

Regulatory professionals can complete the 10-15 minute survey online at http://ow.ly/t2cCP. All responses are confidential and anonymous. Participants receive free advance access to the results, and respondents who have the Regulatory Affairs Certification (RAC) credential will receive one point toward their recertification requirement.

RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE, had this to say about the survey and its implications: "The goal of the Scope of Practice survey is to give us a look at the development of the regulatory profession, monitoring trends and changes in the duties and responsibilities of regulatory professionals. It also gives us an opportunity to look at their career progression and compensation."

For the survey, RAPS is asking those involved in the regulation of healthcare and related products to answer questions about their daily work, employment, compensation rates and background. During the last survey in 2012, nearly 3,000 regulatory professionals from around the world responded at job levels ranging from the new professional to senior executive positions.

Why is it Important?

Why is the survey important? Keramidas says, "Like any profession, the regulatory profession must adapt and evolve. The Scope of Practice research results provide a way of seeing how it has adapted and changed over time, giving us insights that help the regulatory profession respond to changing needs in the field and anticipate what may be coming next. It also provides critical information to RAPS to help the world beyond the regulatory profession understand what those professionals do and its importance."

Compensation Trends and Factors

As of the 2012 survey, regulatory professionals' compensation had grown 29% in a decade. The continued growth was particularly evident among professionals in the US and Canada, as well as certain European countries, including Germany, Switzerland, the Scandinavian nations and Belgium. Other areas saw more modest growth, or there were not enough data to accurately tell. Compensation has been most significantly influenced by employer type, job level, highest earned degree, regulatory experience and total professional experience. Having the RAC credential has also been shown to have a significant impact on compensation, at least for survey respondents in the US, where the data traditionally have been strongest. US-based respondents to the 2012 survey who held the RAC earned 9.25% more than their peers without the credential.

Professionals' Background and Needs

Results from the 2012 survey showed people moving into regulatory with significant prior professional experience. Respondents to the survey reported an almost two-to-one ratio of total work experience to regulatory experience. Once they are in regulatory, says Keramidas, "We have seen increased movement of professionals across product lines-from pharma-oriented jobs to medical devices jobs and vice versa, and we've witnessed an increased involvement in combination products."

Regulatory professionals also must think globally, the 2012 survey showed. There is an increasing need for familiarity with regulations and requirements for many different global markets and different products. Says Keramidas: "There is still specialization, but there is an increasing need for regulatory professionals to understand the broader regulatory landscape."

Emerging Trends

Another trend from the 2012 report was that regulatory professionals are being increasingly called upon to become involved in business and strategic decision making. "The increasing number of regulatory professionals ascending to higher executive level positions played a role in companies and organizations' burgeoning recognition that regulatory expertise can provide valuable insights to drive more effective organizational strategies," Keramidas says.

Other changes tracked by the survey show that regulatory professionals are increasingly engaged throughout the product lifecyle. This makes them more important players in all aspects of the product lifecyle-from research and development through postmarketing activities--whereas years ago, the emphasis was on submissions and compliance.

What Will the 2014 Survey Tell Us?

Many regulatory professionals and employers will be watching closely when the results of the current survey are made available in June. Key questions to be answered include: Are salaries and compensation continuing to trend upward? How much of an impact does the RAC have in 2014? How is the profession evolving and what changes in job responsibilities are evident? Those outside the profession may be looking to glean insight on the traits and backgrounds of successful regulatory professionals.


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