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.
2018 website Visitors by Country
MEMBER JOB TITLES
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.