Regulatory Affairs and Quality Technical
hace 7 días
As Regulatory affairs and Quality technical, you will support all the related activities for the Corify’s products, including but not limited to collecting and summarizing regulatory intelligence, performing regulatory assessments, participation in project teams, providing input for regulatory submissions, and managing the compilation and review of all submissions for completeness and quality.
**What we need**:
- Manage regulatory projects and closely collaborate with Clinical, Regulatory Operations
- Provide tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLAs and international Marketing Authorization Applications and their respective amendments/supplements.
- Coordinate and manage regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content.
- Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems.
- Assist with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.
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Quality and regulatory director
hace 4 semanas
Madrid, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable Gx P and...
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Quality and Regulatory Director
hace 6 días
madrid, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Quality and Regulatory Director
hace 6 días
Madrid, España ARTO A tiempo completoPosition OverviewThe Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Regulatory Affairs Manager
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Madrid, España Cpl Life Sciences A tiempo completoDirect message the job poster from Cpl Life SciencesManaging Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title: European Regulatory Affairs ManagerLocation: Madrid, Spain, HybridRemuneration: Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic,...
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Regulatory Affairs Manager
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Madrid, España Cpl Life Sciences A tiempo completoDirect message the job poster from Cpl Life SciencesPara una comprensión completa de esta oportunidad y de lo que se requerirá para ser un candidato exitoso, siga leyendo.Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title:European Regulatory Affairs ManagerLocation:Madrid, Spain, HybridRemuneration:Competitive salary and...
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