- Cambrex High Point (Charles City, IA)
- …of facilities meet customer and business demands while complying with DEA, EPA, FDA and OSHA regulatory requirements and company standards. In addition to ... plant capabilities, financial reports and planning tools + Thorough understanding of regulatory requirements regarding DEA, FDA , EPA, and OSHA. + Vision… more
- WuXi AppTec (Middletown, DE)
- …and maintenance of User Requirements Specifications. + Ensuring compliance with regulatory requirements ( FDA , EMA, cGMP), quality standards, and safety ... **Overview** This role will design, develop, optimize, and support GMP drug product manufacturing and packaging process, including equipment, facilities, and control… more
- Sanofi Group (Cambridge, MA)
- …patient populations, limited historical data, regulatory pathways (eg, FDA /EMA accelerated approval, orphan drug designation), and innovative trial ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...therapy clinical trials, a rapidly evolving field with unique regulatory and methodological considerations. The intern will engage in… more
- University of Utah (Salt Lake City, UT)
- …at contributing to intellectual property portfolios * Depth of knowledge with applicable regulatory and quality requirements (eg, FDA 21 CFR 820 and ISO ... instruments, and non-surgical medical devices. Conduct activities in compliance with FDA QSR's and ISO 13485. Ideate and develop concepts, develop SolidWorks… more
- Caris Life Sciences (Phoenix, AZ)
- …issued are identified, resolved, and prevented in alignment with regulatory and internal Quality Systems requirements. The Analyst partners cross-functionally ... across laboratory, operational, and customer-facing functions to maintain compliance with FDA , ISO 13485, CAP, and CLIA standards while driving proactive… more
- Koniag Government Services (Silver Spring, MD)
- …and a proven track record of excellence in abstracting data from regulatory applications and scientific reports. **Essential Functions, Responsibilities & Duties may ... comprehensive research, analyze intricate scientific data, and communicate findings to FDA staff and stakeholders. The primary responsibilities of this role include:… more
- Lilly (Indianapolis, IN)
- …digital enablement, and operational excellence across the product lifecycle to meet regulatory requirements and Lilly standards and may also serve as the point ... a strong working knowledge and understanding of regulations, guidelines, and regulatory precedence. **1.** **Case Management Leadership** + Serve as a leading… more
- Abbott (Plano, TX)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... device report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within required timeframes.… more
- ThermoFisher Scientific (Fremont, CA)
- …and operational excellence experience at scale * Strong working knowledge of cGMP, FDA , and other relevant quality/ regulatory requirements . Exposure to global ... 3,200 innovative products, NDX specializes in Drugs of Abuse Testing, Drug Monitoring, Molecular Controls, IVD Controls, Technologies & Companion Diagnostics.… more
- Boehringer Ingelheim (Athens, GA)
- …written and verbal communication skills + Excellence in comprehension/application of FDA /EU/USDA regulatory requirements for production and distribution of ... at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's Validation Master Plan (MVP) and… more