A Regulatory Affairs Specialist is responsible for keeping track of the changing legislation in all the regions in which a company wishes to distribute its products, advise on the legal and scientific restraints and requirements, and collect, collate and evaluate scientific data. They are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned.

They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.