Regulatory affairs

Regulatory affairs is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking or telecommunications. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

Definition

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

Role

Regulatory affairs professionals (RAPs) 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 Medicines Agency (EMA) (pharmaceuticals for human use, medical devices, veterinary drugs, etc.), the Environmental Protection Agency (EPA) (pesticides, industrial chemicals, etc.), and the Consumer Product Safety Commission (CPSC) (toys, appliances, etc.).
• 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.

Regulatory agencies

Regulatory affairs departments are growing within companies due to the increased scrutiny on the industry by such bodies as the FDA, EMA, etc. and the public. Regulatory affairs departments work closely with the FDA, EMA, etc. on product approvals, and all other regulatory issues.

See also

• Food and Drug Administration
• European Medicines Agency
• Environmental Protection Agency
• Consumer Product Safety Commission
• Pharmaceuticals
• Medical devices
• Biologics
• Functional foods