Cate Pedrick Email & Phone Number

United States

-Upload and download regulatory submissions, communications to/from health authority (HA) for Clinical Trial Applications (CTA) onto regulatory repository from electronic transfer area-Scanning and indexing of global regulatory submissions and HA communications, according to established SOPs and standards, ensuring quality and integrity of the metadata-Filing of hardcopies regulatory documents-Quality review of documents for archive in house and offsite records

Critical review of clinical files received from Clinical Study Teams, both in-house and regional - reviewed against standards of what is contained in the local study file onsite. Customer service for retrieval of study files. Resolution of issues with the clinical document checklist and paper documents.

Clinical Submissions regulatory operation support for Ception's Regulatory group, including QC review of draft source documents, compilation of review findings on source and final pdf documents for clinical investigator (CV's, 1572's, IRBs), pre-clinical, IND amendments submissions to the FDA. Generation of pdf files from Word source files, review of electronic source files against functional group released hardcopy masters; review and compilation of hardcopy masters to final operational processing for submission to FDA and other Health Authorities. Preparation of module documents for submission of paper BLA in CTD format.

Provided administrative support and compliance for the submission of regulatory documents for assigned marketed biological products in Global Regulatory CMCDeveloped and managed Regulatory Affairs Chemistry, Manufacturing and Controls (CMC) conformance guides and submission, inspection, and correspondence libraries for 3 major post-approval productsArchival: post-approval CMC regulatory documentation into electronic company database (GRAIL) and file original paper copies for records retention. Review and assesssment of manufacturing and supplier-initiated vendor change controls, driving the submission of regulatory dossiers to the health authorities