Manages the regulatory aspects of projects/products related to clinical trials and product approvalapplications for submission to regulatory agencies, including FDA, Health Canada, EMA, and/or local European agencies as needed to support ProMetic development programs.

Management of Phase 2 Biologic Product Development Program - Provide Regulatory guidance to development team on clinical, nonclinical, and manufacturing development - Manage all Regulatory aspects of active IND dossier, including submission of: meeting requests and briefing documents, responses to Requests for Information, safety reports, clinical protocols and clinical study reports, nonclinical protocols and final study reports, and CMC amendments - Report on product status to US Government SponsorsCo-lead development program for licensed product - Manage submission of supplemental BLA and associated review response documents for new product indication using the Animal Rule - Regulatory oversight of post-marketing registry studyAuthoring and Review of Regulatory Documents - Responsible for primary authoring and review of regulatory submission packages in collaboration with technical writers and functional representatives - Regulatory review of batch records, lab results, deviations, and document revisions related to investigational product manufacture - Collaborate on protocols and reports for CMC, Nonclinical and Clinical areas - Responsible for authoring and posting applicable trial information on clinicaltrials.govProvide regulatory input on government proposals and external diligence activitiesRegulatory Intelligence ActivitiesMember of Global Pharmacovigilance Committee

Maintenance of Phase 1-4 INDs: -Annual Reports -Safety Reporting -Clinical Protocols and Key Study Documents -Nonclinical Development -CMC for Biologics and Small MoleculesImplementation of Labeling SupplementsApplication of FDA Animal Rule

Formatting of controlled documents, including:Annual Product ReviewsAnnual Labeling ReportsAnnual Stability ReportsIND Protocols and ReportsAssembling PDF packages to support PAS, IND, and other regulatory submissions.Issuing and verifying batch records, maintenance and calibration logs, and controlled documents Records retention managementQuality Assurance review of maintenance and calibration logsSpecial projects:Implemented standardized campus procedure for data package preparation for GMP, GLP, and developmental useSAP subject matter expertSupported 2008 and 2009 FDA InspectionImproved and created Document Control internal audits

Maintaining book inventoryAssisting customers

Assisting research faculty and studentsInspecting stock and special ordersFiling and invoicing

Compiling and purchasing special orders and stockCommunicating with regional sales managers and faculty researchersSupervising student employees