The Regulatory Affairs Professionals Society (RAPS) has released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organisations have evolved.
The role of a regulatory professional has never been so crucial, especially in Europe and RAPS’ The 2018 Global Compensation & Scope of Practice Report for the Regulatory Profession aggregates salary data for more than 2300 respondents from 64 countries.
It breaks down median and average salary and total compensation by factors including job title, experience, highest earned degree, certification, and size and type of employer.
Following the 2016 survey, US-based professionals continue to represent the highest percentage of respondents, with European respondents making up the second highest percentage followed by Canada and Asia.
The 2018 survey achieved a slightly higher European respondent percentage than the previous survey. In addition, 63.7% of respondents in 2018 were female with the total number holding approximately 20 years’ experience, 11 years in the regulatory environment and in their current position for 4 years on average. This report was released at RAPS’ annual Regulatory Convergence conference in Vancouver, BC.
“RAPS conducts the Compensation & Scope of Practice Survey every 2 years. It is the only survey of its kind, yielding a wide-ranging picture of the global regulatory profession,” said RAPS executive director Paul Brooks.
“The resulting data is extremely useful to individuals, employers, recruiters and others as a tool for understanding and benchmarking regulatory professionals’ compensation and provides unique insight into multiple aspects of their work and career paths.”
Compensation and Hiring
Median total compensation varies between US and EU. US-based professionals range from $93,000 for associates to $256,500 for vice presidents compared with median total compensation from €60,000 for associates to €120,000 for directors in Europe.
On average, base salary increase in US from 2014 to 2015 was 5.9%, whereas between 2016 to 2017 this was slightly lower at 4.7%. In comparison, the average salary increase from 2016 to 2017 for all European respondents was 4%.
In 2016, more than 18% of European professionals reported holding the Regulatory Affairs Certification (RAC) but this was slightly less in 2018 with 17.1%. The report also indicated that in 2018, US respondents who have the RAC reportedly earn 17.6% more than those without it, on average, which is a significant increase compared with the results from the 2016 survey (11%).
Nearly a third (31.6%) of organisations, globally, increased their regulatory staff in 2017 while almost half (47.5%) of respondents expect their employers to hire additional regulatory staff in 2018–19.
Product Focus and Responsibilities
On the whole, respondents from 2018 mirrored the sentiments of those in 2016 with regards to their specific work focus, reporting their responsibilities have moved well beyond product compliance and registration with their role taking a much more strategic level with a higher rate of multi-geographical responsibility.
Responsibilities vary by job title but overall, an average of 30% of 2018 respondents’ time is spent on post approval tasks; 21.7% is spent on regulatory intelligence and strategy and more than 80% of respondents help shape their organisations’ key strategic decisions, business decisions or both.
On average, in 2018, respondents devote 86% of their time to working on a single, specific type of product (eg medical devices, brand-name pharmaceuticals, generic drugs, etc). More than half spend 100% of their time on one type of product with 41% working primarily with medical devices and 27.3% of respondents working primarily with some category of prescription drugs.
Importance and Recognition
Nearly three-quarters (71%) report that senior management is aware of the work they do and more than half (56.6%) say senior management regards their work as important to the organisation.
Career Path and Motivations
Quality assurance/quality control (18.4%), R&D (11.6%), life sciences research (6.8%) and engineering (6.6%) were common feeder professions.
Asked about important factors influencing their decision to enter the regulatory profession, respondents cited opportunities for advancement, diverse work, ensuring healthcare products’ safety and effectiveness and the need for regulatory professionals as the top reasons.
With so much industry influence pertaining from the regulatory profession, it’s important for RAPS to continue to support its members in Europe to ensure that they are able to stay up to date on the transitional regulatory developments that the market is currently experiencing and remain ahead in their regulatory responsibilities.
More information on The 2018 Global Compensation & Scope of Practice Report for the Regulatory Profession is available here.