The regulatory profession by the numbers: RAPS’ 2020 compensation and scope of practice survey

The RAPS 2020 Global Compensation & Scope of Practice Report for the Regulatory Profession presents an analysis of nearly 2,000 responses from regulatory professionals from around the world who participated in an online survey in April 2020. The following article reviews the main findings from the 2020 report, focusing on regulatory professionals’ levels of education and certification, experience, the most common regulatory functions performed, and career and job motivations. Compensation trends for the US, Europe, and Canada, are also presented, as are salary increases (2018-2019) by job title, geographic region, company size, and area of focus or specialty.
 

Introduction

The Regulatory Affairs Professionals Society (RAPS) has researched the work and compensation of global regulatory professionals in the healthcare products sector every 2 years, for nearly 30 years. The RAPS Global Compensation & Scope of Practice Report for the Regulatory Profession is the largest and most comprehensive study of regulatory professionals, with the resulting findings based on original data that are not available elsewhere.
 
Data in the compensation portion of the survey provide insight into the market value of regulatory work and expertise and reflect differences in salaries based on job level, years of experience, education, and area of specialty/expertise. The scope of practice findings provides a better understanding of regulatory professionals’ priorities and responsibilities and, when considered over time, reflect how the profession has evolved and is changing.
 
For the 2020 survey,¹ 85,000 regulatory professionals around the world received an email in April 2020 inviting them to complete an online survey. A total of 1,949 online responses were received by June 2020, for a response rate of 2.3%. The final results were processed by an independent, US-based professional survey research firm. The report was completed in September 2020.
 
Of note is that questionnaires for the survey were mailed in April 2020, just a few weeks after March 11, when the World Health Organization declared COVID-19 to be a pandemic.
 
Data were obtained for a total of nine reference job levels in the survey – President, Executive Director, Director, Manager, Project Manager, Specialist, Associate, Consultant, and Regulatory Information Specialist (RIS). The survey questionnaire had included six new job titles, but none except RIS received sufficient responses to qualify for inclusion in the final analyses. Professionals, from President to Project Manager, supervise between 1 and 5 individuals, whereas the Associate, Consultant, and RIS generally do not supervise others.
 

Demographic profiles

Geography, job titles, employer type, setting
Three-quarters of survey respondents were based in the US, 8.3% in Europe, and 5.4% in Canada. The largest percentage of US respondents were clustered in the Pacific, South Atlantic, and Mid-Atlantic regions of the country. RAPS members accounted for 73.9% of all respondents.
 
The highest number of respondents had the job title Manager (24.3%), while 19.2% were Directors, 16.9% were Specialists, and 7.4% were Consultants.
 
Just under two-thirds of the respondents were women (63.3%). Men comprised 35.3% of the respondents; 0.2% of respondents said they identified as non-binary, and 0.1% identified as transgender. The highest number of women worked as Managers (72%) or Regulatory Information Specialist (79%). Job titles with the highest number of men included President (52.6%), Consultant (47.6%), and Director (39.1%).
 
In all, 66.3% of respondents reported being employed by industry (specifically, a manufacturer), and 7.6% reported industry, other than manufacturer, as an employer. Of those not working in industry, 8.4% worked for consulting firms, 5.2% were self-employed, and 4.8% worked for a clinical research organization.
 
Almost half the respondents (49.3%) worked in the regulatory department setting, followed by 22.6% in the regulatory/quality and 11.8% in the clinical/regulatory/quality control settings.
 
Education and experience
Regulatory professionals are generally well educated, with almost all of them (around 99%) holding a university degree. Of those with degrees, close to two-thirds (63.7%) indicated they had advanced degrees (master’s, 41.5%; doctorates, 22.2%), and 25.4% had undergraduate degrees. In all, 0.7% of respondents had no degree.
 
Areas of study focus spanned life and natural sciences (47.4% of respondents); engineering (18.4%); clinical science (15.2%); regulatory affairs (12.6%);s and business, finance, and/or economics (12.2%).
 
Respondents typically reported having an average of 17 years of professional experience, with 9 of those years in spent regulatory. They had been with their current employers for about 4 years and in their current positions for about 3.
 
Many reported having worked in other fields or professions before moving into regulatory. Among the feeder fields for those transitioning to regulatory in this way, were quality assurance or control (18.8%), research and development/product development (11.4%), life sciences research (6.9%), and engineering (7.6%). This means many entering the profession come with significant work experience. At the Manager, Project Manager, Specialist, and Associate job levels, the ratio of total professional experience to regulatory experience is typically 2:1 or more, though the ratio decreases as they gain more regulatory experience relative to overall professional experience (Figure 1). For all respondents, the ratio is 1.6 to 1.
 
Figure 1. Ratio of total professional experience to regulatory experience by job level
 

Scope of practice and most common regulatory functions

Respondents were questioned about the scope of practice of their regulatory work based on the product category on which they focused most and the regulatory functions they spent the most time on during the course of a work week. In regard to product category, most respondents (44.1%) indicated they focused on medical devices; 27.9% focused on prescription drugs, including generic drugs, innovative/brand-name pharmaceuticals, orphan products, and active pharmaceutical ingredients; 12.8% and 6.5% on biotechnology and in vitro diagnostics, respectively.
 
The most common regulatory functions performed were: regulatory strategy (respondents report 13.7% of time each week is spent on this function); submissions, including registration and review (12.2%); project management (6.9%); compliance (6.0%); and writing (5.3%). Also clustered around the 5% mark were quality assurance (5.2%) and clinical trials, including design, management, and reporting (5.1%).
 
Parsing focus on function by job level shows how different functions are distributed across or concentrated around the different job levels. For example, the regulatory strategy function tends to center around more senior professionals – Executive Director (18.4% of time each week), Director (17.5%), and Vice President (VP; 16.4%) – whereas submission responsibilities seem concentrated around fewer senior staffers – RIS (20.3%), Specialist (18.5%), and Project Manager (14.1%).
 
Predictably, those at the Project Manager level spend almost a third (29.8%) of the week on project management; compliance seems fairly evenly spread across most job levels (range: 4.8%, Executive Director; 6.5%, Manager), but spikes at 9.7% for the RIS level.
 

Value, recognition, career, and job motivation

On the whole, work done by regulatory professionals seems to enjoy a high level of recognition and appreciation from senior management or executives. Almost three-quarters (72.7%) of respondents said their seniors were “very or somewhat aware” of their regulatory work, and 80% said their seniors view their work as “very or somewhat valuable or important.” The latter number was up significantly from 2018’s 56.5%.
 
In all, 77.7% of respondents said regulatory professions played a role in shaping strategy and business directions in their organizations. Just 14.4% said they were not involved in shaping any of those aspects (Figure 2).
 
Figure 2. Regulatory professionals’ role in shaping strategy and business direction
 

 
A total of 80.7% of respondents cited career advancement as a very or somewhat important driver of their move into the regulatory profession. Other factors driving that decision included the diverse work of regulatory professionals (79.6%), ensuring safety and effectiveness of healthcare products (79%), and job security (70.3%). Once respondents were established within the profession, their reasons for wanting to move to a new position and staying there changed (Table 1; Job Title Profiles, Table 2).
 

 

Compensation for US respondents

The report includes compensation information for respondents based in the US, Canada, and Europe, but there were not enough data to show detailed results for other regions. Three-quarters of responses came from the US, allowing the most detailed aggregation of compensation data for US-based respondents.
 
On average, total annual compensation ranged from $292,625 (base, $238,692) for VPs, to $108, 627 ($99,211) for Specialists, with Directors earning $213,306 ($171,445); managers, $138,172 ($121,618); Project Manager, $131,730 ($119,371); RISs, $120,401 ($106,909); and Associates, $108,887 ($96,394).
 
In general, since 1995, both base and total annual compensation increased steadily through 2019. VPs have seen the steepest annual rates of increase in both base and total annual compensation – about $150,000 during 1995-2019 – whereas Managers have seen a much smaller increase, about $25,000, during the same time. Of note is that salaries for Managers and Specialists dipped noticeably during the 2017-2019 period, and seemingly at the same rates. Salaries for Associates continued to rise from about $60,000 in 2001 and, by 2018-2019, their salaries were the same as those for Specialists, at around $75,000.
 
Drivers of compensation increases
Respondents reported a base salary increase of 5.6% during 2018-2019. Promotion was the main driver of increases during that time. One in five respondents (22.2%) were promoted in 2019 and, as would be expected, they saw a higher increase in their base salary (10.6%) than those who were not promoted (4.2% increase).
 
Another driver of salary increases across all job levels is having the RAPS Regulatory Affairs Certification (RAC). About 42.7% of respondents indicated they had earned the certification. Respondents based in the US and Canada were more likely to hold the certification (48.4% and 51.0%, respectively), with just 17.5% of respondents based in Europe being credentialed.
 
RAC-certified professionals earned 9% more than those without the certification (Figure 3). In particular, Associates with the RAC made 42% more than the Associates who did not have it.

Figure 3. Differences in compensation between regulatory professionals with and without RAPS' Regulatory Affairs Certification, by job level


 
Compensation for regulatory professionals at larger organizations was generally higher than for those working at smaller organizations. For example, Directors at companies with fewer than 10 employees earned a median total compensation of $165,000, compared with those at companies with 10,000 or more employees, who earned $224,500.
 
However, level of education did not seem to have a strong correlation with higher compensation. For example, at the Director level, those with a bachelor’s degree earn around $200,000 a year, compared with those with a doctorate, who earn $215,000. At the Specialist level, earnings for those two degrees would be $97,000 and $100,000, respectively.
 
US regulatory professionals employed in the New England and Pacific coast regions of the country had the highest compensation for all job titles.
 

Compensation for respondents based in Canada and Europe

Data for Canada and Europe were not reported to the same extent as were those for the US. However, Table 3 provides a synopsis of average annual base and total compensation by job level.
 

 

Conclusion: Who is the average regulatory professional?

The “average” regulatory professional responding to the survey is a woman who works in industry for a North American organization with 10,000 or more employees. She holds a master’s degree and works in a department of one to nine people, focuses on medical devices, and is a RAPS member and holds the RAC. She is most likely to be a Manager and has had that title and been with her current company, probably located in New England, for about three years. She has worked in regulatory for 11-20 years, having entered the field as an associate. Most of her work is in regulatory strategy and/or submissions. She works about 45 hours a week and her annual salary is about $165,000. Factors most important to her in relation to her current position are: Work environment, team members, salary and benefits, her relationship with her supervisor, the organization’s mission or purpose, and career advancement.
 
About the author
Randolph Fillmore is a freelance medical and science writer based in Florida. He can be reached at flasciencewriter@gmail.com.
 
Citation Fillmore R. The regulatory profession by the numbers: The RAPS’ 2020 compensation and scope of practice survey. Regulatory Focus. April 2021. Regulatory Affairs Professionals Society.
 
Acknowledgment
This report was conducted for RAPS by Industry Insights Inc, an independent professional survey research firm located in Dublin, Ohio, US.
 
References

1. Regulatory Affairs Professionals Society. 2020 Global Compensation & Scope of Practice Report for the Regulatory Profession. https://www.raps.org/RAPS/media/Careers/RAPS_2020_Compensation_and_Scope_of_Practice_Report.pdf. Released 13 October 2020. Accessed 5 April 2021.