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Manager, Regulatory Affairs
Position Overview Manage the operations of Mary Crowley Cancer Research (MCCR) Regulatory Department to ensure compliance with governmental regulations, guidelines, and industry standards. Direct activities as they relate to clinical trials in the areas of study development and department operations in regulatory / safety. Provide this support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines and Mary Crowley Standard Operating Procedures (SOPs). Managerial Develop and implement departmental goals that align with MCCR’s vision and business goals. Cascade goals down to individual staff’s annual objectives. Oversee the activities of the Regulatory D
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