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Regulatory Affairs Specialist

2 months ago

Durham, North Carolina, United States Duke Health Full time

REGULATORY AFFAIRS SPECIALIST

Duke Health

An exciting position is open for a Regulatory Affairs Specialist at Duke Health. In this role, you will be tasked with executing study-specific regulatory and safety reporting procedures across various projects, ensuring compliance with applicable regulations, institutional guidelines, and study protocols under the supervision of your manager. You may also mentor junior team members and provide training on regulatory compliance.

Key Responsibilities:

  • Prepare submissions for FDA review and collaborate with relevant stakeholders.
  • Address any FDA review concerns in partnership with the Principal Investigator.
  • Develop and submit documentation for Institutional Review Board (IRB) evaluation.
  • Gather and manage data pertinent to research initiatives.
  • Leverage technology to improve research methodologies.

Qualifications:

  • Completion of an Associate's degree.
  • A minimum of two years of experience in research and/or regulatory affairs.

Job Code: REGULATORY AFFAIRS SPECIALIST

Job Level: 52

Duke Health is an Affirmative Action/Equal Opportunity Employer dedicated to fostering diversity and inclusion. The organization values the exchange of ideas and perspectives to cultivate a community that encourages collaboration and innovation.