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What Is a Regulatory Affairs Labeling Specialist?
The regulatory affairs industry works to control the safety and efficacy of a range of products, including: pharmaceuticals, medical devices, pesticides, agricultural chemicals, cosmetics, food, etc. and the companies who research, manufacture, and market these products. Regulatory affairs professionals can be employed in industry, academic institutions, government agencies, and clinical research organizations (CROs), among others. A regulatory affairs labeling specialist is responsible for creating, updating, and maintaining labeling records throughout the life of a product. They will ensure that products meet regulatory labeling requirements for US and international distribution.
|Educational Requirements||Bachelor's at minimum; Master's preferred|
|Job Skills||Written and verbal communication skills, interpersonal skills, attention to detail, data entry, management|
|Median Salary (May 2019)*||$65,586 (for all regulatory affairs specialists)|
|Job Outlook (2016-2026)**||8% (for all compliance officers)|
Sources: *Payscale.com; **U.S. Bureau of Labor Statistics
Regulatory affairs professionals can come from a variety of educational backgrounds, utilizing their training in areas such as science, pharmacy, engineering, marketing, and business for a successful career. Most earn a bachelor's in life science, clinical science, public health, or engineering, but there are also those who earn a bachelor's in unrelated areas, such as business, economics, or liberal arts. Prospective employers tend to focus more on finding candidates that have advanced regulatory expertise and hands-on experience; therefore, many regulatory professionals pursue a graduate degree or concentrate on job training to sharpen their skills. Advanced degrees in the sciences or, specifically, regulatory affairs are usually pursued.
There are professional organizations for regulatory affairs professionals that offer training and certificate programs that can boost your resume. The Regulatory Affairs Professionals Society (RAPS), The Organisation for Professionals in Regulatory Affairs (TOPRA), and The Center for Professional Innovation & Education (CfPIE) are examples of these organizations. The FDA also offers regulatory affairs courses online and around the country.
Different skills will be required of labeling specialists depending on the industry they are working in, but knowledge of current FDA and USDA labeling regulations and global product labeling regulations will be standard. A labeling specialist will create product labels and maintain databases of labels, ingredients, and formulas; therefore, a strong attention to detail and efficiency in proofreading, data entry, and database management is essential. Adherence of good manufacturing practice (GMP), quality, and safety practices will also be required.
Labeling specialists not only interact with regulatory affairs teammates but also cross-functionally with clinical, medical, legal, safety, commercial, quality, and supply chain associates, so they must have excellent written and verbal communication skills and interpersonal skills.
Career Outlook and Salary
The U.S. Bureau of Labor Statistics reports that employment of compliance officers, including regulatory affairs specialists, is projected to grow 8% from 2016-2026, which is about as fast as the average for all careers; however, as new and developing industries become more regulated, the need for additional regulatory specialists should increase. The median salary for all regulatory affairs specialists is $65,586 as of 2019, as reported by Payscale.com.
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