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🥝 Regulatory Affairs Coordinator
Katalyst Healthcares & Life Sciences | Boston, Massachusetts, United States | Posted May 15, 2026
Job Description
Responsibilities:
- The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials.
- This role ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site.
- They will support clinical research teams by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects
- S/he will be responsible maintaining accurate and up-to-date regulatory files.
- S/he will serve as a central regulatory resource for staff conducting clinical research.
- This position reports to the Director of Research Services.
- Prepare...