The report was compiled from the results of a survey of regulatory professionals around the world working in the healthcare product sector who answered questions about their professional roles and responsibilities, compensation and demographic profile. More than 3,000 responses were received from 55 different countries. The survey, conducted every two years, is the most comprehensive report on the global regulatory profession.
The results show regulatory professionals are taking on a wider range of responsibilities, including becoming increasingly involved in critical business functions. Despite the economic downturn since the previous survey in 2008, overall compensation continued on an upward trend, although it grew at a slightly slower pace. The report also points to the continuing globalization of the profession, increased involvement with multiple product types and 6% higher compensation for professionals with Regulatory Affairs Certification (RAC).
“The regulatory profession is increasingly seen as a vital area within the healthcare product sector,” said RAPS Executive Director Sherry Keramidas, PhD, CAE. “These data show that regulatory professionals are becoming more involved in business and strategy, and that they are increasingly called upon for expertise on multiple regulatory systems and requirements throughout the world as well as their application to a number of different products. That expertise is very valuable.”
Together, business and strategy occupy more than 28% of survey respondents’ time. In addition, the number of respondents who reported pursuing business education was up compared with the previous survey in 2008. These data underscore the regulatory profession’s important position at the intersection of business, emerging healthcare technologies and government regulation.
Other important findings included in RAPS’ report include:
US respondents with the RAC credential reported average total compensation that was 6% higher than their peers without the RAC. Forty-four percent of all survey respondents are RAC certified. The percentage of RACs is especially high in Canada (54%) and the US (47.2%). A little more than 21% of European-based respondents reported having the RAC. Overall, about 34% of respondents said they were involved in comparative effectiveness research and reimbursement, up from 23% in 2008. Half of all senior-level respondents reported being involved in government affairs. About 70% of respondents said their work is either global in nature or focused on multiple regions of the world. More than 68% reported involvement with multiple product types, a 6.3% increase from 2008. Overall, just 5.7% reported working with biosimilars, a product category that was added to the survey for the first time, but 22% of respondents from Asia and Latin America reported involvement with biosimilars. Nearly all respondents have a university degree; many have advanced degrees. The percentage of respondents whose highest degree earned is a master’s is up to 37.5%, a 17.2% increase from 2008. The percentage of respondents with MBAs and postgraduate certificates also increased. Respondents reported significant professional experience outside regulatory, an indication that many have transitioned into regulatory from another, related field. Most have educational backgrounds in life sciences, clinical sciences or engineering.
RAPS members have free access to the 2010 Scope of Practice & Compensation Report for the Regulatory Profession. For a complimentary copy of the report, members of the media may contact Zachary Brousseau, senior manager, communications, RAPS, at zbrousseau@raps.org or +1 301 770 2920, ext. 245. An additional version with expanded salary data will be available for purchase from the RAPS Bookstore.
About RAPS
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org
