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Concept
Regulatory affairs
Summary
Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).
Regulatory affairs professionals (aka regulatory professionals) usually have responsibility for the following general areas:
Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
The regulatory function in healthcare industries 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. The most significant responsibility of a regulatory professional in an export company is to get a product successfully registered and approved by the health agency of the country like FDA (Food and Drug Administration) for USA, or EMA (European Medicines Agency) for Europe.
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 postmarket surveillance.
Official source
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