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Food and Drug Administration (FDA)

Silver Spring, Maryland

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Denver, Colorado

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Nemours

Wilmington, Delaware

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Wilmington, Delaware

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Miami, Florida

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Boston, Massachusetts

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East Lansing, Michigan

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Queens, New York, New York

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Beverly Hills, California

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Wilmington, Delaware

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Denver, Colorado

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Beverly Hills, California

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Denver, Colorado

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Remote Eligible, Maryland

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Gainesville, Georgia

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Rockville, Maryland

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Denver, Colorado

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Denver, Colorado

National Center for Advancing Translational Sciences

Rockville, North Carolina

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Regulatory Affairs Specialist 2
Serves as the primary specialist on regulatory affairs processes for clinical research studies. Maintains knowledge of changing regulations and policies governing clinical research and assesses the impact of such changes on the regulatory affairs department. Manages, implements, and evaluates all aspects of regulatory activities and strategies including submissions and facilitation of responses at time of study initiation, execution/maintenance and close out. Explains regulations, policies and procedures to guide others on regulatory and compliance matters. Creates reports and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulations, and institutional processes. Ensures study protocol submissi


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