Senior Regulatory Affairs Associate



Summary

The Senior Regulatory Affairs Associate works to support the Office of Surgical Research, associated investigators, and study teams. This position supports all aspects of regulatory compliance for a large portfolio of clinical trials that include multi-site industry, NIH–sponsored and Principal investigators initiated clinical trials. This support includes assisting with the submission of protocols and IND and IDE submissions to the FDA and relevant institutional review boards. Ideal candidate must have a proven tracking record of research regulatory support at an academic medical center or hospital and have broad knowledge of the IRB and FDA process and regulations.

Job Duties
  • Acts as the department’s representative and primary contact relative to regulatory affairs.
  • Manage activities of regulatory affairs and the preparation, review, and submission of documents to the IRB, FDA, NIH, industry sponsors, and other academic centers.
  • Provide regulatory advice to multidisciplinary teams on the regulatory requirements to support clinical development, including preparation and maintenance of IND and IDE fillings.
  • Lead and facilitate activities, including team preparation, for meetings with sponsors, FDA, and other regulatory authorities.
  • Responsible for ClinicalTrials.gov Registration and maintenance (when applicable).
  • Interface with sponsors, regulatory authorities, and monitors as needed.
  • Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks.
  • Oversee and ensure compliance with regulatory procedures and work practices.
  • Monitor study accrual and conduct Q & A assessments as needed.
  • Support study monitoring, as needed and requested.
  • Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team.
  • Assist with and prepare for FDA meetings, inspections, and audits from regulatory agencies.
  • Track changes in regulatory guidelines as they may occur.
  • Prepare updates on laws, regulations, and guidelines for distribution to appropriate study personnel and investigators.
  • Maintain working knowledge of regulatory changes through guidelines, articles, writings, and courses.
  • Regulatory Affairs will assist the Principal Investigator and research coordinators in the data collection and submission of event reports including but not limited to non-compliance, adverse events, serious adverse events, unanticipated problems, and protocol deviations/violations.


Minimum Qualifications
  • Education Required: Bachelor's degree.
  • Experience Required: Four years of relevant experience.
  • Certification/Licenses/Registration: None Required.


Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

5361

CA; CH

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