The Regulatory Affairs Department provides a crucial link between the company, its products and the regulatory authorities. Within the company, our regulatory professionals must negotiate effectively across a broad spectrum of disciplines, from manufacturing and clinical, to marketing and legal. Externally, we have responsibility for communicating and arbitrating with both the European Medicines Agency (EMEA), national European agencies such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and other agencies in the rapidly expanding International territories. The Regulatory Affairs Department plays a pivotal role in presenting the scientific evidence to the regulatory authorities that the quality, safety and efficacy testing of the product are appropriate for the proposed prescribing information. This role begins right at the drug discovery stage and continues for as long as the drug is on the market.

A sub-function of our department, the Document Records Centre (DRC), is responsible for the administration, storage, retention and eventual archiving of the majority of Amgen's essential regulatory & clinical study documentation in support of submissions to regulatory authorities.