- Lundbeck (Deerfield, IL)
- …clinical societies, and alliances (eg, Rare Disease Caucus, PFDD Consortium, FDA Rare Disease Center of Excellence). + Highly proactive, solution-oriented, and ... for a rare disease. + Past responsibility for managing IIT process. + FDA regulatory knowledge and direct exposure. **TRAVEL:** + Willingness/ability to travel up to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and/or warehouse, logistics, production manufacturing experience in a regulated industry ( FDA , USDA, NRC) obtained within the last 5 years OR Two ... and/or warehouse, logistics, production manufacturing experience in a regulated industry ( FDA , USDA, NRC) OR Three years of warehouse experience in a… more
- ThermoFisher Scientific (Middletown, VA)
- …reagent production activities. + Oversee quality assurance processes to ensure compliance with FDA 21 CFR Part 820, ISO 13485, IVDR, and GMP requirements. + Partner ... or technical leadership roles. + Experience with quality system regulations and standards ( FDA QSR, ISO 13485, ISO 14971, GMP). + Hands-on experience with CAPA, root… more
- 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
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