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Regulatory Affairs specialist

Company: Katalyst Healthcares & Life Sciences
Location: Rochester
Posted on: March 20, 2023

Job Description:


  • Oversee the smooth-running of regulatory processes at the site(s).
  • Assist in formulating and carrying out Standard Operating Procedures (SOPs).
  • Review SOPs with Clinical Operations lead to ensure they abide by local, state, GCP, ICH, and FDA guidelines.
  • Ensure all required regulatory documents and IRB submissions are completed in a timely manner.
  • Ensure clinical staff completes the study initiation checklist prior to patient screening.
  • Regularly perform quality checks for all regulatory documents.
  • Participate in kick-off meetings to ensure all regulatory documents are in place.


    • 5years of regulatory experience in a hospital, clinical or healthcare setting.
    • Experience with Central IRBs and Local IRBs.
    • Knowledge and understanding of regulatory terminology, regulations (including HIPAA policies and procedures), clinical trials, and GCP concepts.
    • clinical research experience is highly preferred!

Keywords: Katalyst Healthcares & Life Sciences, Rochester , Regulatory Affairs specialist, Other , Rochester, New York

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