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Director of Regulatory Affairs, Clinical
The Director of Regulatory Affairs, Clinical reports to the Executive Director, Regulatory Affairs, and will manage the regulatory development and approval of drug products as well as establish and maintain compliance with global regulations and requirements. PRIMARY JOB FUNCTIONS Responsible for developing global clinical regulatory strategies for development and late-stage programs Lead regulatory interactions with global regulatory agencies for development and late-stage programs Support the compliance of manufacturing (drug product and drug substance) and clinical development organizations Author and review key regulatory documents required for global drug product submissions such as responses to agencies’ requests, ame


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