Regulatory affairs (RA) provides a crucial link between pharma companies and regulatory authorities. Without the RA department, pharma companies couldn’t bring any drugs to market because they’d be unable to meet the required legislation to licence their products.
RA departments need scientists to collate and evaluate scientific data, write clear arguments and explanations for new product licences/licence renewals/licence variations, and prepare submissions. These scientists work as medical writers, preparing all the documentation needed for RA.
But what exactly does an RA Medical Writer do? And how can you break into RA?