Regulatory affairs (RA) is a dynamic and challenging profession that is vital to making safe and effective healthcare products available worldwide. RA encompasses a variety of disciplines and job responsibilities, which may begin during the product development and continue into when a product is widely available for use.
RA professionals are employed in industry, government and academia and are involved with a wide range of products, including:

• pharmaceuticals
• medical devices
• in vitro diagnostics
• biologics and biotechnology
• nutritional products
• cosmetics and
• veterinary products

The professionals' roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post-market surveillance.

Core Competencies
RA professionals come from diverse backgrounds. Most RA professionals have earned a bachelor's degree, and over half have an advanced degree, most often in a scientific or technical field. RA professionals usually have experience in other careers before transitioning into regulatory affairs. Often, they have worked in the fields of medicine, nursing, pharmacy, engineering, clinical laboratory science, research or healthcare manufacturing.
Although some university degrees and graduate certificates are being developed, experience is a key asset for RA professionals. Other valuable skills include project management/organizational skills, negotiation and communication skills and the ability to learn from the experience of others, both inside and outside the organization.

Continuing education and professional development are critical to the RA professional. RA professionals must keep up-to-date with regulatory policies and procedures for one or more countries as well as maintain an understanding of the scientific and technical background of products. Many RA professionals seek opportunities to expand their business-related skills, including project management, communication and financial management.