Regulatory Affairs Jobs in Nebraska
1 - 15 of 31
Search Results - Regulatory Affairs Jobs in Nebraska
ClinLab Solutions Group-Omaha-
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...
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Insmed-Lincoln-
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...
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Blue Bully Recruiting LLC-Lincoln-
and related documentation.
• Ensure compliance with USDA and other global regulatory requirements.
• Lead quality risk assessments using risk-based methodologies.
• Work closely with Manufacturing, R&D, Regulatory Affairs, Supply Chain and Technical Operations...
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Insmed-Lincoln-
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...
Read more
Penfield Search Partners Ltd-Lincoln-mindmatch.ai-
Operations, Data Management, Statistical Programming, Medical Writing, Regulatory Affairs, and Pharmacovigilance teams.
• Oversee and manage CROs and external statistical programming vendors to ensure high-quality deliverables, timeline adherence...
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Insmed-Omaha-
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...
Read more
Medica Services Company LLC-Omaha-
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...
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Insmed-Omaha-
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...
Read more
Insmed-Omaha-
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...
Read more
Insmed-Lincoln-
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...
Read more
Insmed-Lincoln-
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...
Read more
Medtronic-Omaha-
Medical safety and risk management
• Post-market surveillance
• Regulatory affairs knowledge (FDA, EU MDR)...
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Medtronic-Lincoln-
Medical safety and risk management
• Post-market surveillance
• Regulatory affairs knowledge (FDA, EU MDR)...
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Illumina-Omaha-
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...
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Illumina-Lincoln-
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...
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