- Tractor Supply Company (Brentwood, TN)
- …the Harmonized Tariff Schedule, Customs regulations and other government agency requirements ( FDA , EPA, DOT, USDA etc) + Process documents through the company's ... the Harmonized Tariff Schedule, Customs regulations and other government agency requirements ( FDA , EPA, DOT, USDA, etc.) + Solid knowledge of domestic and… more
- Abbott (Altavista, VA)
- …resolution of customer inquiries. + Guarantee compliance with DOT, IATA, GMP, ISO, FDA regulations, and ensure all employees are properly trained. + Oversee Customs ... systems and cGMP requirements** , with experience managing operations under FDA and third-party audits. + **Strong analytical, communication, and project management… more
- Mentor Technical Group (Monroe, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... biotech, or medical device industry). + Knowledge: + Familiarity with GMP, FDA , and regulatory requirements for packaging operations. + Understanding of Good… more
- Bristol Myers Squibb (Indianapolis, IN)
- …support regulatory filing. . Review and author CMC sections for IND/NDA for FDA submissions, and support regulatory filing in other jurisdictions, eg EMA, Health ... radiopharmaceuticals. **Skills and Qualifications** . Strong understanding of GMP, FDA /EMA regulations, and ICH guidelines. . Strong problem-solving abilities and… more
- Bristol Myers Squibb (San Diego, CA)
- …Advise on global regulatory matters relevant to radiopharmaceuticals, including FDA regulations governing drug development, clinical trials, approval, labeling, ... in the biotech, pharmaceutical or life sciences industry, including significant FDA regulatory and healthcare law counseling. + Prior experience supporting oncology,… more
- AbbVie (Waco, TX)
- …departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates ... + Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities. + Ability to work with mathematical concepts such… more
- Lundbeck (Deerfield, IL)
- …disease alliances and policy groups (eg, Rare Disease Caucus, PFDD Consortium, FDA Rare Disease Center of Excellence) + Highly proactive and solutions-oriented, ... for a rare disease + Past responsibility for managing IIT process + FDA regulatory knowledge and direct exposure **TRAVEL:** + Willingness/ability to travel up to… more
- Terumo Neuro (Aliso Viejo, CA)
- …+ Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room monitoring and validation activities, ... four (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring. 4. EN… more
- ADM (Olivia, MN)
- …destination (rail cars or bagging). Maintains awareness and adheres to all FDA , GMP, BATF, EPA, OSHA and employer standards and guidelines. Suggests improvements ... and that safety is everyone's responsibility Maintains awareness and adheres to all FDA , GMP, BATF, EPA, OSHA and employer standards and guidelines. ADM requires the… more
- BayCare Health System (Tampa, FL)
- …ClinicalTrials.gov, and prepares and submits IND or IDE applications to the FDA for BayCare-sponsored projects as required. + Required skills includes extensive ... knowledge of FDA regulations and human subject protection, regulatory knowledge and compliance, leadership and team management, operational oversight, communication… more