- Lilly (Indianapolis, IN)
- …with current local and international regulations, laws, guidance's (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... + Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation… more
- Terumo Neuro (Aliso Viejo, CA)
- …execution and operational excellence in accordance with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs. Provide oversight of site ... with the protocol, GCP, company SOPs, and all applicable regulations (eg, FDA ). + Understand, read, prepare, and deploy study documentation including, informed… more
- Boehringer Ingelheim (Orlando, FL)
- …specialist role responsible for pull-through of the account plan (developed by the Account Manager ) at the Health System's various sites of care and with the Health ... Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company...Previous account management experience. + Various regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company… more
- Arena Technical Resources, LLC (Rockville, MD)
- …seeking a Senior Appian Developer in Rockville, MD to join our team supporting the FDA . The Food and Drug Administration ( FDA ) is the federal agency responsible ... food supply, cosmetics, and products that emit radiation. The FDA is also responsible for: advancing the public's health...performance issues, etc. - Work closely with the release manager to ensure completion of key tasks including deployment,… more
- Good Sense Foods (New Hope, MN)
- …leads the sanitation team, monitors work, ensures compliance with regulatory guidelines ( FDA , USDA, SQF, etc.), and works closely with production and quality ... Understand and ensure compliance with all Good Manufacturing Practices (GMPs), HACCP, FDA , USDA, and BRC standards. * Maintain accurate sanitation records, including… more
- Pentax Medical (Montvale, NJ)
- …In this role, the specialist will work under the guidance of a seasoned manager to ensure PENTAX Medical's products for Endoscopes and Speech, Voice and Swallowing ... and manufacture of Speech, Voice and Swallowing products. + Facilitate all FDA registration and listing related activities. + Manage interactions with US Customs… more
- US Tech Solutions (North Chicago, IL)
- …and maintain **complaint files,** in compliance with regulations established by the FDA and international regulatory bodies, and submit safety reports to the ... FDA and international Competent Authorities. + In addition will...determine and document the conclusion(s). + Assist Supervisors and Manager in monitoring complaint and claims workflow to ensure… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in a GMP aseptic manufacturing environment preferred. + Experience working with FDA or other regulatory authorities is preferred. **Skills and Qualifications** + ... regulations and guidance. + Knowledge and proven experience in FDA , EMA, or other regulatory authority. + Well-practiced in...+ US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to… more
- Bristol Myers Squibb (Indianapolis, IN)
- …documents to support regulatory filing. . 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 the… more
- Bristol Myers Squibb (Indianapolis, IN)
- …manages a cross-functional team, and ensures alignment with regulatory requirements (cGMP, FDA , USP, and other relevant bodies). The ideal candidate has extensive ... Strong knowledge of pharmaceutical validation practices, including cGMP and FDA /USP/OSHA regulatory requirements. + Expert understanding of facility, utility,… more