Regulatory Specialist - Clinical Research
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POST DATE 8/31/2016
END DATE 10/23/2016
Technical Resources International Inc.
Managing the lifecycle of investigational applications (INDs, NDAs, BLAs, IDEs, etc.) and ensure compliance in accordance with GCPs/ICH and all applicable FDA regulations.
Preparing scientific and regulatory documents (e.g. clinical protocols, investigator s brochures, informed consent forms, annual reports, investigational new drug applications, new drug applications, regulatory correspondence, and clinical summary reports).