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Otsuka America Pharmaceutical Inc.
Princeton, New Jersey
University of North Carolina at Chapel Hill, Office of Human Research Ethics (IRB)
Chapel Hill, North Carolina
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Raleigh, North Carolina
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Regulatory Affairs Manager
The Regulatory Affairs Manager will support regulatory activities of our organization to ensure compliance with domestic and international regulations and standard operating procedures. This individual must demonstrate effective teamwork by developing collaborative relationships with internal and external personnel, as well as through highly effective oral and written communication skills. ESSENTIAL FUNCTIONS Assist with the preparation and submission of regulatory agency applications, reports, or correspondence. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Provide regulatory guidance to departments or development project
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