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The Nature of Regulatory Affairs
Since the early 1960's, there has been an ever-increasing public and government interest in the safety and efficacy of pharmaceutical and medical device products. This interest has been accompanied by a growing number of regulations that regulatory agencies, such as the Food and Drug Administration, have imposed upon the health care product industries. Failure to comply with any one of the requirements can delay the approval of a new pharmaceutical or medical device product, resulting in the loss of millions of dollars to the sponsoring company. This increase in regulatory requirements for pharmaceutical and medical device products has dictated that companies in these industries establish a distinct department, staffed with uniquely qualified professionals to assure that all these requirements are met. These individuals are known as regulatory affairs professionals.
The Regulatory Affairs Professional
Since the regulations for pharmaceutical and medical device products cover a broad spectrum of product development, approval and marketing functions, the regulatory affairs professional is typically involved in many aspects of any one project over a period of many years. Additionally, the regulatory affairs professional must not only remain current with the rapidly changing regulations, but must also have a reasonable working knowledge of many aspects of the development process, including chemistry, pharmacology, toxicology, clinical research, statistics, manufacturing, quality control, advertising and marketing. At the same time, it is important that the regulatory affairs individual have an understanding of the workings of the regulatory agency or agencies.
The regulatory affairs professional utilizes all of these skills in three key functions of their role during the product development process. First, they interpret the regulations and advise their coworkers of the impact of these regulations and requirements on the design and quality of the studies and reports conducted to demonstrate the safety and efficacy of the product under development. Secondly, they prepare the submissions required to move the development of the product into the clinic, and the final submission to gain approval for commercialization of the product. Finally, they serve as the chief negotiators with reviewers at the regulatory agency during the review and approval process. In summary, the regulatory affairs profession is largely a communication function, both within the company and externally as the company's regulatory expert. Through effective communication, it is their responsibility to help the company avoid deficiencies in data and delays in approval of the products.
In larger companies, with substantial numbers of regulatory affairs staff members, there is often division of these responsibilities into areas of subspecialization. Some RA staff members will be responsible for the preparation of submissions, maintenance of these documents and, often times, for direct negotiations with regulatory agency reviewers. Others will be involved with compliance aspects of the study and manufacture of the products; they will assist in the establishment of systems to assure that data and products are of consistent high quality. Still others, usually senior staff members, may be involved in the development of strategies for the study of each new project to determine ways to shorten the time required for study and approval of the product. In smaller companies, all of these functions may be the responsibility of one or two individuals.
Skills Important for the Regulatory Affairs Professional
With the responsibilities of regulatory affairs professionals summarized above, it is not surprising that these individuals must possess outstanding communication skills, both written and oral. They must be able to write summaries of technical information that are accurate, clear, concise and complete. They must also be able to effectively communicate aspects of the regulations to others within the organization, assist in applying those regulations in a practical manner to the company’s systems, and motivate their coworkers to comply with these requirements. It is important that this be done in a manner where it is evident that the regulatory affairs professional is part of the product development team. This involves interpersonal skills and sensitivities. Furthermore, the regulatory affairs professional must be able to communicate with the reviewers of their data, and interpret the questions the regulatory agency staff members ask during the review process. Finally, with all of these interactions, the regulatory affairs professional is often required to utilize tactful negotiation skills.
Another important quality for regulatory affairs professionals is a keen attention to detail. As part of the review of study protocols to be sure that they will provide the best data to establish safety and efficacy of the product. Similarly, an eye for detail is important in reviewing study reports. Finally attention to detail is important as the regulatory affairs professional prepares, reviews and finalizes the key regulatory documents for submission to the regulatory agency.
That the regulatory affairs profession involves communications of regulations and highly technical information, it is evident that those in the field must possess education sufficient to comprehend the various, diverse areas of research and development of health care products. In most cases this dictates an educational background in the sciences, i.e., biology, chemistry, biochemistry or in the case of medical devices, even engineering. While an education at the B.S. degree is sufficient, the most successful regulatory affairs professionals often possess M.S. or Ph.D. degrees in the sciences.
It nearly goes without saying that the regulatory affairs staff members must possess knowledge of the regulations, regulatory guidelines and guidances. These regulations are constantly changing, and, even when the actual regulation does not change, the regulatory agency’s interpretation or application of these regulations may change. In an industry where products are typically developed for marketing in not only the U.S., but key international markets such as Europe and Japan, the regulatory affairs professional must also have some appreciation and understanding for the differences in the regulatory requirements in these other areas of the world.
In Summary
The skills that are required in regulatory affairs include a strong educational background in the appropriate sciences, outstanding written and oral communication skills, an attention to details, and excellent interpersonal skills. Professionals in this field will be rewarded with an occupation that is varied from day to day, and one that will provide the satisfaction of having made a significant contribution to the availability of important new health care products.
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