The profession known as "Regulatory Affairs" developed because in almost all countries of the world, governments have responded to public concern over public health and product safety in a number of areas (such as pharmaceuticals, veterinary medicines, medical devices, pesticides and the like) by placing requirements on manufacturers to conform to stringent safety testing procedures and obtain marketing authorisations (product licences) before placing products on the market.

Companies having products subject to such legislation have established specialist departments staffed by regulatory affairs professionals whose job it is to keep track of the legislation in all the regions in which the company wishes to distribute it's products. Such professionals also advise on the legal and scientific restraints and requirements, collect, collate, evaluate scientific data and present registration documents (dossiers) to regulatory agencies and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisations for the products concerned.

Regulatory affairs personnel must ensure that the product information submitted to the authorities is as complete as possible and in the correct form. They are also responsible for subsequent contacts with the regulatory authorities. Since authorisations are issued for a specified time and have to be renewed before expiry, a very important part of the regulatory affairs function consists of the maintenance and updating of existing authorisations and in handling the inevitable variations that crop up from time to time.

It may take anything up to 15 years to develop and launch a new pharmaceutical or medical product and many problems may arise in the process of scientific development. It is the job of the regulatory affairs professional to help the company avoid deficiencies in their data which may create difficulties in the registration of the product. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising. The regulatory affairs department will accordingly take part in the development of the product marketing concepts and is usually required to approve packaging and advertising before it is used commercially.

Most people working in this area have a degree in biochemistry, toxicology, pharmacology, pharmacy, physiology, nursing, medicine or a related discipline. And further training is provided by the British Institute of Regulatory Affairs for it's 2,500 members, including a diploma or masters degree in Regulatory Affairs at the University of Wales. Trainees spend many weekends in Cardiff working through the modules and write a thesis if they want to convert their diploma into an MSc.