Regulatory Systems Management Expert
4 days ago
Genmab is seeking an experienced system manager to join its Digital Systems Management team. The successful candidate will be responsible for maintaining, developing, and operating GenDocs, a global IT system based on Veeva Vault.
The ideal candidate will have a strong background in IT systems management, particularly with EDMS systems and Veeva Vault. They will work closely with the line of business departments to understand their needs and implement new features and functions to improve business processes.
The role involves close collaboration with the team, line of business departments, and vendors to configure and develop systems. Excellent communication skills are essential for this position, as the candidate will interact with internal stakeholders and external vendors.
- Lead and contribute to the optimization and innovation of GenDocs and related processes
- Participate in daily system management work, including configuration, implementation, and validation of new system features and functions
- Responsible for resolving daily issues and incidents from users of the systems
- Maintain system documentation during operation
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Quality Management System Expert
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Regulatory Affairs Expert
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Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeAs a Regulatory Affairs Expert at Radiometer Danmark, you will play a critical role in ensuring compliance with applicable standards and regulations within the organization. You will be responsible for handling quality management systems and supporting processes, participating in and driving smaller projects in the RA/QA function with manageable risks and...
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Regulatory Systems Management Lead
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the PositionThe System Manager will be responsible for implementing new IT functions and features in GenDocs to improve and optimize business processes, especially in regulatory systems management. The ideal candidate will have extensive experience with EDMS systems, preferably Veeva Vault administration and platform certification, as well as a strong...
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Regulatory Affairs Systems Manager
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Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark / Danaher is a leading provider of diagnostic solutions. Our purpose is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for...
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Product Regulatory Affairs Expert
3 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeWe are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We strive to learn what happens beyond the surface and show up every day ready to engage and have fun with each other. Our vision is to solve the global need for radiologists while ensuring every patient receives expert-level care.As a Quality Management System Professional, you...
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IT Systems Manager Regulatory Affairs
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled System Manager to join its Digital Systems Management team. As a key member of this team, you will be responsible for implementing new IT functions and features in our electronic document management system (EDMS), GenDocs, which is based on the Veeva Vault cloud platform. Your primary goal will be to improve...
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Site Activation and Regulatory Expert
3 days ago
Copenhagen, Copenhagen, Denmark IQVIA LLC Full timeJob OverviewWe are seeking a highly skilled Site Activation and Regulatory Expert to join our team in the Nordics region.The successful candidate will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to local and international regulations, standard operating procedures (SOPs), project...
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Regulatory Compliance Expert
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Copenhagen, Copenhagen, Denmark AJ Vaccines Full timeJob SummaryWe are seeking a Regulatory Compliance Expert to join our Pharmacovigilance and Safety Team at AJ Vaccines. In this role, you will be responsible for ensuring that our operations are compliant with international regulations and guidelines.Key ResponsibilitiesEvaluate and manage global pharmacovigilance reportsDevelop and maintain SOPs and...
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DCS Systems Commissioning Expert
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Copenhagen, Copenhagen, Denmark Meet Life Sciences Full timeAutomation Expert for Pharmaceutical Manufacturing CompanyThis mid-senior level position involves working as an automation expert for a large scale project in the pharmaceutical manufacturing industry. As an automation engineer with expertise working on ABB DCS systems (800xA), you will configure, troubleshoot, and commission on a critical...
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Regulatory Compliance Expert
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Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeJob DescriptionOur company is seeking a Regulatory Compliance Expert to join our Emerging Technologies API Manufacturing Development (ET API MDev) team. In this role, you will be responsible for ensuring compliance with GxP guidelines and regulations, supporting management in setting the direction for the department on quality challenges and...
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Nuclear Regulatory Oversight Expert
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Copenhagen, Copenhagen, Denmark NTU International AS Full timeNTU International A/S is leading a consortium for the implementation of the EU funded project called: Strengthening Egyptian nuclear safety and radioprotection regulatory infrastructure and is searching for experts to support the core team during the implementation of this project. The overall objective of this action is to strengthen the nuclear safety...
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Regulatory Compliance Specialist
3 hours ago
Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full timeWe are seeking a highly skilled Regulatory Compliance Specialist to join our Life Cycle Management (LCM) Product team at Sandoz International GmbH. As a key member of our team, you will be responsible for ensuring the regulatory compliance of marketing authorizations across multiple countries and product portfolios.This role requires close collaboration with...
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Data Management Expert
5 days ago
Copenhagen, Copenhagen, Denmark Ubique Systems Full timeJob OverviewWe are seeking an experienced Data Management Expert to join our team at Ubique Systems.About the RoleThis is a mid-senior level contract position requiring 2+ years of experience in business analysis with master data management. The ideal candidate will work in a hybrid mode, 3 days a week from office, and be responsible for driving entity...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
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Global Regulatory Strategy Expert
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout This OpportunityWe're looking for an experienced Global Regulatory Strategy Expert to join our team at Genmab. As a key member of our Global Regulatory Affairs organization, you'll play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects. Your expertise will be essential in ensuring regulatory compliance and...
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Regulatory Affairs Expert
5 days ago
Copenhagen, Copenhagen, Denmark CareerArc Full timeCareerArc is seeking a seasoned Regulatory Affairs Expert to lead the development of our open banking business in Europe. As a key member of the Global Regulatory Team, you will play a critical role in shaping our strategy and ensuring regulatory compliance across multiple jurisdictions.About the RoleIn this role, you will advise on supervision and...
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Regulatory Manager
4 days ago
Copenhagen, Copenhagen, Denmark Nordea Full timeKøbenhavn S, DK, 2300 Job ID: 23315 Are you passionate about navigating regulatory changes and staying ahead of the regulatory trends? We are seeking a dynamic Regulatory Manager to join our team and support our organization in analyzing the impact of upcoming EU and local Nordic regulatory changes. At Nordea, we're committed to being a partner our...
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Regulatory Expert in Nuclear Safety
3 days ago
Copenhagen, Copenhagen, Denmark NTU International AS Full timeNTU International A/S is leading a consortium for the implementation of the EU funded project: Strengthening Egyptian nuclear safety and radioprotection regulatory infrastructure.The overall objective of this action is to enhance the nuclear safety and radioprotection regulatory framework of the Egyptian Nuclear and Radiological Regulatory Authority...
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Regulatory Manager
2 days ago
Copenhagen, Copenhagen, Denmark Nordea Full timeKøbenhavn S, DK, 2300Job ID: 23315 Are you passionate about navigating regulatory changes and staying ahead of the regulatory trends? We are seeking a dynamic Regulatory Manager to join our team and support our organization in analyzing the impact of upcoming EU and local Nordic regulatory changes.At Nordea, we're committed to being a partner our customers...