Regulatory professionals play critical roles throughout the healthcare product lifecycle, from concept through product obsolescence. They provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world. Continuous evolution in science and changes in the regulatory environment, healthcare sector and general economics shape the dynamic and expanding scope of the regulatory professional. Regulatory professionals must continually grow their knowledge and skills to be effective and to advance in their careers.
Scope of Practice
Regulatory professionals at all career and experience levels are involved in activities throughout the product lifecycle, and most are involved to some degree in bridging the gap between regulatory-related functions and organization and business activities. As expected, there are variations in time allocations among job levels, and there are differences in the type and level of involvement, including supervisory, direct involvement and support functions.
Compensation Overview
As in most professions, regulatory professionals' salary and overall compensation is affected by a number of related factors. Regulatory work is knowledge based, so experience, expertise and education all play a significant role in job performance and, ultimately, compensation. 2010 Scope of Practice & Compensation Report for the Regulatory Profession examines the impact on salary and compensation of the following key variables: title; regulatory experience; professional experience; number of employees supervised; hours worked per week; highest degree earned and professional degrees (e.g. MD, PharmD, PhD, JD, MBA); years in current position; gender and organization type.
Professional/Regulatory Experience
Most individuals enter the regulatory profession with prior professional experience. Many have previous experience in scientific and clinical research, clinical laboratory work, clinical professions such as medicine or pharmacy, quality and manufacturing. Prior work experience tends to be closely related to education and training areas.
Product Type
The majority of regulatory professionals are involved with multiple product types. The most common product types are medical devices, combination products, pharmaceuticals, active pharmaceutical ingredient (APIs), biologics and biotechnology.
Multinational vs. National/Regional Focus
At all levels, regulatory professionals typically have a multinational, multiregional and/or worldwide focus. A good portion of individuals who have a national/regional scope of work will most likely devote at least some time to international submissions and compliance.
Employment Setting
Regulatory professionals work in diverse mix of employment settings and for employers of various sizes. The greatest number of regulatory-related professionals worldwide work in the industry sector. Other sectors employing regulatory professionals include government, academic institutions, clinical research organizations and other research organizations.
Education
The regulatory profession is a knowledge-based field, so it is not surprising to find that nearly all regulatory professionals have a higher education degree and the majority has some post baccalaureate education and/or graduate degrees.
Degree Trends/Areas
The majority of regulatory professionals have degrees in science––particularly in the life sciences or clinical sciences––and/or engineering. There is also a growing trend of individuals pursuing advanced education in business. For those holding a doctorate, the majority have a PhD in the life sciences or clinical sciences. In addition, a small percentage of the regulatory population holds a medical or veterinary degree or a professional pharmacy degree.
Regulatory Affairs Certification (RAC)
The RAC credential is the only professional certification available specifically for the regulatory profession. The RAC credential is attained by passing a knowledge-based examination. Currently, there are four RAC examinations (US, European Union, Canada and General Scope). This certification is very popular within the profession and strengthens the value and credibility one brings to an organization. The RAC credential may be particularly important for individuals at early and mid-career levels.