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Regulatory affairs (RA) within the biomedical/health products sector is a relatively young, multidimensional profession that is international in scope. At its core, the RA profession facilitates the collection, analysis, and communication about the risks and benefits of health products to regulatory agencies, medical care systems, and the public. Operationally, RA is responsible for assuring that government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system.

Regulatory affairs professionals are employed in industry, government, and in academic research and clinical institutions. The full scope of regulatory affairs varies somewhat among organizations. However, regulatory affairs professionals play a pivotal role in facilitating the progression of new health products and technology through the product life cycle (see figure).


History

The regulatory affairs profession began to emerge as a health-related profession in the 1970s, initially in the United States. By the late 1980s, the profession was becoming recognized internationally and the demand for RA professionals grew. During this time, many felt that a professional certification program was needed, so in 1991, the Regulatory Affairs Certification (RAC) was introduced. By 2003, more than 3000 professionals worldwide held the RAC designation. The RAC is an examination-based certification with examinations offered for U.S. and/or E.U. regulatory processes. An examination for Canadian regulatory processes will be offered in 2004.

RA Professionals

The RA profession blends knowledge from the sciences, regulation, law, and business as well as other subspecialties. The diversity of the scope of the profession, its pivotal role in the dynamic biomedical/health sector, and the opportunity for professional growth is making regulatory affairs an attractive profession for new and established individuals. Salary levels of RA professionals showed steady growth throughout the 1980s and '90s. A North American survey indicated that the average salary of RA professionals was over $93,000, an increase of nearly 13% from 1999 levels [Data from the 2002 RAPS Salary].

The majority of RA professionals (over 85%) hold a degree in the life sciences, clinical sciences, or technical sciences/engineering. According to the 2002 North American survey, approximately 60% of professionals hold at least a master's degree and nearly 20% have a doctorate degree. Graduate degrees include specializations in the sciences, engineering, clinical professions, business, and law. Recently, graduate programs in regulatory affairs have been established, but less than 1% of current professionals have a degree in RA.

Job Responsibilities

RA professionals are essential to all aspects of the drug development process including preparing, submitting, and monitoring submissions to regulatory agencies, addressing issues raised in the regulatory review process, managing reports, and tracking and other postmarketing functions. However, RA professionals are increasingly involved with products during the research and development phases, in the design and monitoring of clinical studies, marketing, advertising, and communications. They are also involved in aspects of manufacturing, packaging and distribution, and business strategy, particularly as related to international regulatory submission strategies and policies. The RA profession is typically the source of information on international regulatory issues, with a significant number of RA professionals monitoring and analyzing regulatory issues for multiple nations and regions of the world.

Health Products

The health product sector encompasses diverse products, including biotechnology, tissue, combination, and veterinary products, medical devices, pharmaceuticals, biologics, nutriceuticals, and cosmetics. Although the regulations and processes related to these products differ, most regulatory professionals develop and maintain an understanding of the regulatory aspects of these areas. As a matter of fact, recent data from the Regulatory Affairs Professionals Society (RAPS) indicate that more than 60% of RA professionals are involved with multiple product lines.

Regulatory Affairs Professionals Society

RAPS represents the health product regulatory affairs profession and individual professionals worldwide. RAPS was instrumental in the emergence and growth of the profession and continues to supply research on RA's current and future scope. RAPS supports the development of professional standards and certifications and provides access to training, education, and professional development, including career services for new and senior professionals and other knowledge services. RAPS also serves as a neutral facilitator of discussions about directions in biomedical research and the implications for regulatory processes worldwide.

In conclusion, the pharmaceutical drug industry depends upon RA professionals to provide necessary regulatory information about health products. Their work continues to benefit consumers worldwide.

Sherry Keramidas, Ph.D., CAE, is executive director of the Regulatory Affairs Professionals Society and may be reached at skeramidas@raps.org.