In this weekly feature, the editors of SpringBoard highlight one career in the health care professions–including a basic description, educational requirements, core competencies/key skills needed, and related web sites and professional organizations where you can find more information!
A regulatory affairs specialist is in charge of making sure that a drug company is complying with legal and regulatory requirements. Regulations come into play at all steps of the process from research to marketing, including conducting clinical trials, applying for the FDA approval (or approval from agencies in other countries), and manufacturing the drug. A regulatory affairs specialist ensures that an application for a new drug contains all the necessary documents and information. During the research stages, a regulatory affairs specialist examines plans for clinical trials, ensures they conform to requirements, and keeps track of what forms must be submitted and what information must be reported. There are also regulatory affairs specialists involved in drug advertising and promotion. Responsibilities include reviewing advertising copy and label information to be sure they contain essential information and don’t make any claims that aren’t allowed.
Education and Certification
Most regulatory affairs specialists have at least a bachelor’s degree, and a major in a scientific or health-related field is helpful. Many have completed at least some graduate work or hold higher degrees. There are now some degree and certificate programs specifically in regulatory affairs, but it is not yet clear how important this type of background will be. Experience in research, laboratory work, clinical medicine, pharmacy, or a related area is often expected, and experience with the FDA is helpful. Experience with project management can also be useful. Some jobs require specialized knowledge, such as an engineering background for work related to medical devices. Companies may also look for employees with certain certifications. Regulatory affairs specialists may be more competitive if they hold Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.
Core Competencies and Skills
■ Patience with paperwork
■ Ability to understand complex technical and legal language
■ Strong sense of ethics
■ Basic understanding of science, medicine, and research principles
■ Familiarity with applicable federal requirements
■ Good computer skills, including word processing and spreadsheets
■ Ability to keep important company information confidential
A salary in the range $50,000 to $60,000 is not unusual for a lower-level job. An experienced regulatory affairs specialist can earn a salary in the $100,000 range.
Regulatory affairs specialists involved in health care work primarily for industry, and sometimes for medical centers, universities, research companies, or other organizations that must meet certain requirements.
Because pharmaceutical and medical device companies can’t run without making sure they comply with regulations, these jobs will likely be secure. In recent years, companies have had difficulty finding qualified people to do this work, but they are often looking for seasoned professionals. One way to get started is to begin with a company in a different role and look for opportunities to learn about regulatory affairs.
For Further Information
■ Regulatory Affairs Professionals Society (RAPS)