Regulatory affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. The field of Regulatory affairs includes all aspects of drug development such as research and development, animal and human clinical trials, marketing, and approval.
The Regulatory affairs professional typically has a background relevant to the business in which they work, i.e., science, law, or engineering. Regulatory affairs 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 (FDA) or European Medicals Agency (EMA) (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.
The syllabi of most medical regulatory affairs training programs includes subjects as diverse as product portfolio regulatory management, regulatory impact of product or company acquisition, strategic alliances, skills and competencies for the regulatory affairs professional, politics of regulation, supply chain management, intra-company interface management and communication technology and skills.
The Regulatory affairs professional typically has a background relevant to the business in which they work, i.e., science, law, or engineering. Regulatory affairs 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 (FDA) or European Medicals Agency (EMA) (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.
The syllabi of most medical regulatory affairs training programs includes subjects as diverse as product portfolio regulatory management, regulatory impact of product or company acquisition, strategic alliances, skills and competencies for the regulatory affairs professional, politics of regulation, supply chain management, intra-company interface management and communication technology and skills.