Clinical Regulatory Affairs Associate Job in Columbus, Ohio US
Clinical Regulatory Affairs AssociateSpecific Responsibilities: Receive documents from various sources and review for completeness and suitability for submission to FDA. Request and correct missing and/or illegible pages, arrange for translations as needed. Review regulatory documents to assure FDA requirements are met and are ready for submission. Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies. Duties include the compliance with stringent regulations and laws of IND submissions and financial disclosures. Read more […]