Regulatory affairs

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 industries (pharmaceuticals, medical devices, biologics and functional foods).

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including: The regulatory professional's roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and postmarket surveillance.

Global aspects of regulatory affairs are taken up by organisations such as the Drug Information Association (DIA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The European Model for medical device has largely been adopted by the Global Harmonization Task Force as the international template.