With pressure to contain the cost and time it takes to create new products and bring them to market, professionals with expertise in regulatory affairs are highly sought after by pharmaceutical companies and medical device manufacturers, as well as by hospitals, health maintenance organizations (HMOs) and a range of other health care oriented organizations as well. The expertise of a DRA professional may be used in areas such as clinical trials, manufacturing, compliance, patenting, sales and marketing, IT, finance and scientific writing.Employment opportunities include:Collecting data and preparing submissions to regulatory agenciesAssisting in the development of procedures to ensure regulatory complianceInterfacing with regulatory agenciesFacilitating identification and resolution of scientific and regulatory issues with regulatory agenciesRemaining current with federal and international regulations and communicating that information within the organization, including the creation of training materialsParticipating in the development of new products and servicesParticipating in quality auditsIn addition to a strong background in pharmaceutical science and regulatory affairs, a successful DRA professional should have excellent interpersonal and communication skills, high ethical standards, attention to detail and strong organizational skills.
Applicants for graduate study must have a conferred bachelors degree, or its equivalent, from an accredited institution prior to the start of the program.