药物监管事务理学硕士

迫于压力，他们需要控制开发新产品并将其投入市场的成本和时间，因此制药公司和医疗设备制造商以及医院，健康维护组织（HMO）都强烈要求具有法规事务专业知识的专业人员。以及其他一系列面向医疗保健的组织。DRA专业人士的专业知识可用于诸如临床试验，制造，法规遵从性，专利，销售和市场营销，IT，财务和科学写作等领域。演示精通高级课程中获得的法规事务的广泛教学基础。通过接触重要的监管项目和案例研究将其知识转化为实践的强大技能。利用专业技能，例如统计分析，监管指导文件的知识以及书面和口头交流技巧。展示对医疗产品法规事务
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.<br><br>Employment opportunities include:<br><br>Collecting data and preparing submissions to regulatory agencies<br>Assisting in the development of procedures to ensure regulatory compliance<br>Interfacing with regulatory agencies<br>Facilitating identification and resolution of scientific and regulatory issues with regulatory agencies<br>Remaining current with federal and international regulations and communicating that information within the organization, including the creation of training materials<br>Participating in the development of new products and services<br>Participating in quality audits<br>In 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.