Pharmacists in regulatory affairs

By virtue of their training, the pharmacist is well qualified to deal with a wide range of activities.

Most countries require government approval to conduct a clinical trial and almost all require a medicine to be approved or licensed before it can be marketed.  A career in regulatory affairs would involve you in these complex and fascinating regulatory processes that are designed to protect the public by ensuring that all new medicines are safe and effective. A good submission can greatly add to the commercial value of a product by avoiding any unnecessary regulatory delay.

Regulatory Authorities

The requirements of Regulatory Authorities exert a considerable influence on the development, manufacture and marketing of medicines. Whether it be chemical characterisation of the active drug substance or its impurities, design of toxicology and clinical programmes, stability, manufacturing method or the advertising claims for the product, the Regulatory Affairs Department becomes involved. Once a medicine is on the market, continuing surveillance of its safety through pharmacovigilance is essential throughout its life.

On the other side of the coin, many pharmacists who have experience in the industry are employed by the Regulatory Authorities to assess submissions from companies for new or modified medicines. This includes examining results from clinical trials, development studies, manufacturing trials and inspecting the factories themselves.