About regulatory

The regulatory profession is vital in making safe and effective healthcare products available worldwide. 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 regulatory professionals.

Regulatory 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

• veterinary products

The regulatory professional's 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.

About rAPS

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers:

• education and training

• professional standards

• publications

• research

• knowledge sharing

• networking

• career development opportunities

• and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence

RAPS is headquartered in suburban Washington, DC, with chapters and affiliates worldwide.

RAPS Membership Demographics

RAPS is comprised of over 16,000 regulatory professionals across the globe. In 2017, the RAPS European member base grew by approximately 19% to more than 1,500 members across 29 countries.

RAPS members work with a variety of regulated healthcare and related products:

• 56% reported working with medical devices and IVD's

• 55% reported working with pharmaceuticals

• 15% reported working with biologics or biotechnology products

• 14% reported working with medical foods or nutritional products

Additionally, over 70% of RAPS members reported working for an organization involved with multiple types of products.

Why do regulatory professionals engage with RAPS?

RAPS is the ONLY organization to provide such a depth of services to support this role including:

• professional standards

• publications

• research and case studies

• knowledge sharing

• networking

• career development opportunities

• Regulatory Affairs Certification (RAC)

40% of members reported working at the director level or higher, with the majority in decision-making capacities.