Regulatory affairs is a profession that deals with an organizations adherence to regulatory compliance. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals, energy, banking, and telecom. Regulatory affairs professionals, also known as regulatory compliance professionals, usually have responsibility for the following general areas:

• Advising their companies on the regulatory aspects and climate that would affect proposed activities.
• Describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
• Collaborating with their companys Offices of Government Relations, Public Relations, Legal-General Counsel, and others to accomplish their goals.

Regulatory affairs departments are responsible for ensuring manufacturers compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device, and biologic product industries, these phases include research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. Regulatory affairs specialists analyze new and existing regulations in relation to an organizations products or processes. They also review marketing, legal, and technical documentation, including case files and clinical research reports, to assess compliance with global regulatory agency policies, regulations, and standards.

Regulatory affairs specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. They help review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. They must be able to work in a demanding environment where strict timelines and protocols must be met. Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations. They must have excellent communication, negotiation, and project management skills.

In summary, regulatory affairs is a profession that ensures compliance with regulatory requirements in various industries, including pharmaceuticals, medical devices, cosmetics, agrochemicals, energy, banking, and telecom. Regulatory affairs professionals are responsible for advising their companies on regulatory aspects, collaborating with other departments, and ensuring compliance with global legislative and regulatory requirements at each stage of product development. Regulatory affairs specialists analyze regulations and assess compliance with global regulatory agency policies, regulations, and standards. They must have excellent communication, negotiation, and project management skills, as well as attention to detail and the ability to adapt quickly to changing regulations.