Regulatory Affairs Jobs in Omaha
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Search Results - Regulatory Affairs Jobs in Omaha
InsmedOmaha
correspondence and submissions accurately; ensure lifecycle management activities
Key requirements
• Bachelor’s degree in a scientific discipline
• 10+ years in Global CMC Regulatory Affairs or relevant pharma/biotech development experience
• 5+ years of gene...
ClinLab Solutions GroupOmaha
Responsibilities
• Maintain regulatory binders and essential documents for active oncology trials after study activation
• Prepare and submit IRB continuing reviews, amendments, safety reports, and protocol deviations
• Manage sponsor and FDA...
InsmedOmaha
correspondence and submissions accurately; ensure lifecycle management activities
Key requirements
• Bachelor’s degree in a scientific discipline
• 10+ years in Global CMC Regulatory Affairs or relevant pharma/biotech development experience
• 5+ years of gene...
Medica Services Company LLCOmaha
Active Pharmacist license required
Preferred Qualifications
• Experience in pharmacy operations, clinical programs, utilization management, analytics, regulatory affairs, or related health plan/PBM functions preferred.
• Strong knowledge of pharmacy...
InsmedOmaha
correspondence and submissions accurately; ensure lifecycle management activities
Key requirements
• Bachelor’s degree in a scientific discipline
• 10+ years in Global CMC Regulatory Affairs or relevant pharma/biotech development experience
• 5+ years of gene...
MedtronicOmaha
Medical safety and risk management
• Post-market surveillance
• Regulatory affairs knowledge (FDA, EU MDR)...
IlluminaOmaha
Management, Regulatory Affairs, Market Access, Legal, Compliance and Commercial teams
• Contribute to publication planning and external scientific communications
• Maintain independence and compliance with regulations governing medical affairs...
IlluminaOmaha
Management, Regulatory Affairs, Market Access, Legal, Compliance and Commercial teams
• Contribute to publication planning and external scientific communications
• Maintain independence and compliance with regulations governing medical affairs...
IlluminaOmaha
Management, Regulatory Affairs, Market Access, Legal, Compliance and Commercial teams
• Contribute to publication planning and external scientific communications
• Maintain independence and compliance with regulations governing medical affairs...
IlluminaOmaha
Management, Regulatory Affairs, Market Access, Legal, Compliance and Commercial teams
• Contribute to publication planning and external scientific communications
• Maintain independence and compliance with regulations governing medical affairs...
MedtronicOmaha
including competitors
• Collaborate with researchers, clinicians, and regulatory affairs to gather information and ensure accuracy
Key requirements
• Bachelor
• Minimum of 4 years of clinical/medical/scientific writing experience or advanced degree with 2...
AcrisureOmaha
to Regulatory Affairs, Risk, Compliance, Sourcing, HR, etc., with capabilities like template filling, data extraction, contract analysis, drafting, and jurisdictional alignment
• Facilitate ideation sessions and lead technical build-out after teams are trained...
MedtronicOmaha
and lifecycle decision-making
• Respond to safety inquiries from internal stakeholders, healthcare professionals, and regulatory agencies
• Collaborate with Medical Safety, Clinical, Regulatory Affairs, Risk Management, and Quality teams on emerging safety...
US PharmacopeiaOmaha
advisor to pharmaceutical developers and manufacturers
• Create User Forums, Quality Hours, Workshops and Webinars with Scientific Affairs, Regulatory Affairs to showcase USP value
• Partner with regional distributors for aligned, resource-shared, joint...
AcrisureOmaha
to Regulatory Affairs, Risk, Compliance, Sourcing, HR, etc., with capabilities like template filling, data extraction, contract analysis, drafting, and jurisdictional alignment
• Facilitate ideation sessions and lead technical build-out after teams are trained...
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