REGULATORY AFFAIRS PROFESSIONAL CERTIFICATION (RAPC)

Regulatory affairs are 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.
Individuals who ensure regulatory compliance and prepare submissions as well as those whose main job function is clinical affairs or quality assurance are all considered RA professionals.
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.

Regulatory affairs professionals play pivotal roles in the development, approval and surveillance of safe and effective health products worldwide, ensuring compliance with applicable laws and regulations.
The profession (al) is a vital bridge between innovators, healthcare providers, consumers and others so that science, medical needs, ethical considerations and the public’s interests are addressed. Regulatory affairs professionals guide health-enhancing products through the regulatory journey by providing the knowledge and understanding to protect public health, reduce suffering and preserve human potential.