
学历文凭
Masters Degree

专业院系
康复治疗

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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.
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