Sample interview questions: Can you describe your experience with the management and oversight of infectious disease clinical trial regulatory submissions?
Sample answer:
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Experience managing and overseeing regulatory submissions for infectious disease clinical trials:
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Managed and coordinated the preparation, submission, and review of regulatory documentation, including clinical trial applications (CTAs), investigator’s brochures (IBs), and amendments for infectious disease clinical trials to regulatory authorities in various countries.
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Collaborated closely with cross-functional teams, including clinical operations, data management, medical writing, and regulatory affairs, to ensure compliance with regulatory requirements and timely submission of all required documents.
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Conducted thorough reviews of regulatory submissions to identify gaps, inconsistencies, and areas for improvement, and provided feedback to ensure submissions were complete, accurate, and scientifically sound.
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Monitored the status of regulatory submissions and maintained effective communication with regulatory agencies to address queries, provide additional information, and respond to requests for clarification.
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Developed and implemented strategies for proactive regulatory engagement, including participating in pre-submission meetings and teleconferences wit… Read full answer
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