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Regulatory Specialist - Clinical Research Sportism

2.0 - 5.0 years

10 - 14 Lacs

chennai

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Position Overview The Regulatory Specialist II supports the planning, preparation, and maintenance of essential regulatorydocumentation required for clinical research studies This role ensures compliance with federal, state, and local regulations, as well as internal policies and procedures The Regulatory Specialist II collaborates closely with Operations, Quality, and Compliance teams to ensure all regulatory activities are completed accurately and on schedule Key Responsibilities Prepare, submit, and maintain IRB submissions, including initial, continuing review, amendment, promptly reportable event, and closure documents Maintain electronic Investigator Site Files (eISF), ensuring essenti...

Posted 1 day ago

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