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Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found 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 ...
Regulatory agencies deal in the areas of administrative law, regulatory law, secondary legislation, and rulemaking (codifying and enforcing rules and regulations, and imposing supervision or oversight for the benefit of the public at large). The existence of independent regulatory agencies is justified by the complexity of certain regulatory ...
Regulatory affairs, alternatively referred to as government affairs, constitutes a profession within regulated sectors like pharmaceuticals and medical devices. Professionals, including statisticians, in these fields are expected to incorporate regulatory guidance into their work practices.
The International Organization for Standardization (ISO) and its ISO 37301:2021 (which deprecates ISO 19600:2014) standard is one of the primary international standards for how businesses handle regulatory compliance, providing a reminder of how compliance and risk should operate together, as "colleagues" sharing a common framework with some nuances to account for their differences.
Obligational awareness refers to the ability of the organization to make itself aware of all of its mandatory and voluntary obligations, namely relevant laws, regulatory requirements, industry codes and organizational standards, as well as standards of good governance, generally accepted best practices, ethics and community expectations.
The role of legal compliance has also been expanded to include self-monitoring the non-governed behavior with industries and corporations that could lead to workplace indiscretions. [6] Within the LGRC realm, it is important to keep in mind that if a strong legal governance component is in place, risk can be accurately assessed and the ...
If you’re stuck on today’s Wordle answer, we’re here to help—but beware of spoilers for Wordle 1273 ahead. Let's start with a few hints.
Regulatory ethics is a body of law and practical political philosophy that governs the conduct of civil servants and the members of regulatory agencies. It addresses issues such as bribery and the relationship of civil servants with the businesses in the industries they regulate, as well as concerns about transparency, freedom of information ...