Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and bankingThe experts for all your software needs: eCTD, NeeS, IDMP, RIM, Validation! Enhance your efficiency with LORENZ. Over 1150 installations. Worldwide customer base. For industry & agencies. 30 years of experience.Regulatory affairs specialists focus on ensuring organizations are meeting all of the applicable regulations, such as those established by the Food and Drug Administration, for products and services. These specialists do so by completing and filing paperwork with the appropriate local, state, and federal agencies.ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical stability guidelines for industries. ICH stability guidelines for stability conditions and testing are followed throughout the world for product quality.Regulatory affairs specialists work at the interface between business and government regulations, shepherding medical products from inception to market. ... The pressure can be intense--but it's important work, and for scientists with the right mindset it can be an excellent career.