Regulatory affairs departments in pharmaceutical companies ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to monitor and control safe and effective use, and the quality of products. Pharmaceutical physicians working in regulatory affairs are one important link between a company and its products and medical assessors in regulatory authorities, including the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
To deliver a quality service, regulatory affairs teams must ensure that a company’s products comply with the regulations of the relevant regulatory authority. In order to do this, they must have knowledge of international legislation, guidelines and customer practices in all countries that the company is exporting to. Physicians collate and evaluate the scientific data gained from clinical trials and develop the submission papers for new product licences and licence renewals. They provide strategic advice to senior management throughout the development of a new product and manage regulatory inspections.
Pharmaceutical physicians are responsible for reporting unexpected or serious suspected adverse drug reactions to the regulatory authorities.