Manager Of Regulatory Affairs

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Manager Of Regulatory Affairs
The candidate works with Histocompatibility, Cord Blood Bank and Stem Cell Laboratory directors, supervisors and managers to assure efficient reporting and safe, pure and potent product and testing release. Assists quality unit with review and performing audits, CAPA reports, and document control. Works with managers and supervisors to design study protocols and set up validations and verifications. Consults with managers and supervisors on IRB protocols. Reviews and approves validation and verification proposals and final summary. Provides review of all quality management programs and interactions with UCD BMT staff and quality interactions. Provides annual quality summaries for Histocompatibility, Cord Blood Bank and Stem Cell Laboratory quality program tracking and trending for quality improvement recommendations. Prepares FDA annual reports and safety reports and works with contracting agency for FDA report eCTD and SPL formatting. Provides semi-annual FDA licensed product (BLA) distribution reports. Reviews proposed change control for FDA CBE, CBE-30 and PAS supplement reporting and approval. Communicates with FDA on BLA and IND submission requirements. Sits on SCTOD CIBMTR outcome committees to assure accurate and timely HPC infusion outcome reporting. Compiles HPC patient outcome reporting data for ClinImmune Labs Cord Blood Bank and Stem Cell Laboratory director, supervisor and manager review. Provides and reviews annual submission of reports to accrediting agencies to maintain CLIA deemed status and CMS compliance. Oversees and reviews Histocompatibility, Cord Blood Bank and Stem Cell Laboratory proficiency testing compliance. Serves as the primary contract for accreditation, registration, certification, licensure status of ClinImmune Labs. Assists Histocompatibility, Cord Blood Bank and Stem Cell Laboratory with SOP content and structure requirements. Reviews regulatory, accreditation and guidance updates for required process control changes. Works with Cord Blood Bank and Stem Cell Laboratory to assure labeling compliance with current required formats. Works with ClinImmune Labs business manager to provide quality content to agreements and contracts. Provides quality review summary to ClinImmune Labs business manager for annual reports for grant funding. Works with Clinical Trials coordinators and contract manufacturers to set up and communicate ClinImmune Labs’ role in new projects. Reviews project manager proposed processes for compliance with federal guidelines and accreditation compliance. Must have a bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis. Master’s Degree, PhD or JD degree strongly preferred. Medical Technologist Certification from the American Society of Clinical Pathology desired.

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