• Clinical Research Physician -- Development

    Lilly (Indianapolis, IN)
    …+ Supports/assists in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the… more
    Lilly (07/16/25)
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  • Automation Technician (2nd shift)

    Herbalife (Winston Salem, NC)
    …degree in Automation/Electronics or Industrial Maintenance Technology/Mechatronics * Food and Drug Administration ( FDA ) or other regulatory experience ... * 5+ years of work experience in a high-speed manufacturing environment * Food manufacturing or packaging experience, and/or blending equipment, batching operation systems **PHYSICAL DEMANDS:** In general, the following physical demands are representative of… more
    Herbalife (05/15/25)
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  • Director US Labeling & Registration

    Bayer (NJ)
    …timely and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling ... evaluates requests for new or revised labeling initiated by FDA or Bayer HealthCare Pharmaceuticals and manages action required...using layman terms; + Solid knowledge of procedures in drug development and maintenance; + Analytical regulatory … more
    Bayer (08/07/25)
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  • Clinical Research Physician - Development

    Lilly (Indianapolis, IN)
    …Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the… more
    Lilly (07/25/25)
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  • Associate Director, Process Engineering

    Cambrex High Point (Charles City, IA)
    …comply with regulatory requirements, including those of the DEA, EPA, FDA , and OSHA. The Associate Director, Process Engineering will drive process improvements, ... + Regulatory Compliance: + Ensure that all engineering activities meet regulatory requirements, including DEA, FDA , EPA, and OSHA regulations. + Lead… more
    Cambrex High Point (07/11/25)
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  • Post Market Surveillance Analyst III

    Abbott (Burlington, MA)
    …(EMS), and other regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating… more
    Abbott (07/11/25)
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  • Manufacturing Process Specialist

    J&J Family of Companies (Wilson, NC)
    …efforts. + Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA , EMEA). + Maintains various databases of ... to thrive in a multi-cultural and matrixed environment. + Knowledge of FDA /EMEA regulatory requirements related to biologics and/or pharmaceuticals, preferred. +… more
    J&J Family of Companies (08/01/25)
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  • Senior Director, Manufacturing Science…

    BeOne Medicines (Pennington, NJ)
    …resolving complex production related issues. + Familiarity with EMA and FDA regulatory requirements for process development submissions. **Other ... critical aspect of the role. + Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements. +...operations at various scales. + Familiarity with EMA and FDA regulatory requirements for process development submissions.… more
    BeOne Medicines (05/31/25)
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  • Oracle Health Clinical Solutions Consultant

    Huron Consulting Group (Van Buren, AR)
    …microbiology-specific coding (eg, LOINC, SNOMED CT), along with a strong understanding of regulatory requirements such as CLIA, CAP, and FDA guidelines specific ... our healthcare clients, ensuring alignment with their strategic goals and regulatory requirements *Provide insights on Oracle Health's Cerner system workflows,… more
    Huron Consulting Group (07/18/25)
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  • Mgr of Quality Bone Marrow Transplant - Hybrid

    Rush University Medical Center (Chicago, IL)
    …(NMDP), American Society for Transplantation and Cellular Therapy (ASTC), Food and Drug Administration ( FDA ), College of American Pathologists (CAP) and Centers ... cellular therapy. * Experience with FACT, CAP, AABB and/or FDA inspections. * Experience in quality assessment, process improvement...of cellular therapy such as nursing, medical technology, or regulatory * Training in Lean Six Sigma or other… more
    Rush University Medical Center (06/10/25)
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