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Clinical Trial And Regulatory Manager Jobs

Clinical Trial And Regulatory Manager
By ImCare Biotech At Doylestown, PA, United States
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all relevant guidance documents, and assigned study protocol(s).
Working with third party consultants as needed to manage related regulatory submissions and/or communications with the FDA.
Minimum of 5 years experience in Clinical Research
Diagnostics-related clinical study experience preferred
Experience with FDA communications/submissions, including Q-subs, 510k, and/or de novo submissions preferred.
ACRP or equivalent certification is preferred