Regulatory Compliance Lead
17 hours ago
We are looking for a Regulatory Compliance Lead to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory processes.
Responsibilities:- Leading the development and implementation of SOPs to ensure regulatory compliance and operational excellence.
- Compiling and formatting regulatory submissions in eCTD format, ensuring accuracy and compliance.
- Implementing and optimizing our new Publishing Tool, leveraging your knowledge of EDMS systems and workflow optimization techniques.
- Streamlining workflows and driving efficiency within Regulatory Affairs, identifying opportunities for process improvements.
- Supporting submission processes for National, MRP, and DCP procedures, as well as regulatory lifecycle management and interactions with CMOs and health authorities.
This is an exciting opportunity to work in a dynamic environment and contribute to the growth and success of Macure Pharma.
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Regulatory Compliance Manager
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is committed to delivering high-quality products and services that meet the needs of patients and healthcare professionals. We're looking for a skilled QA Senior Manager to lead our quality assurance efforts and ensure compliance with regulatory requirements.This is an exciting opportunity to join a dynamic team and contribute to our mission of...
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Regulatory Compliance Specialist
21 hours ago
Copenhagen, Copenhagen, Denmark Eupry Full timeAbout Us: Eupry is a leading provider of temperature monitoring solutions for regulated industries. We are committed to delivering high-quality, compliant products and services that meet the evolving needs of our customers.Job Description: We are seeking a highly skilled QA / QC Specialist to join our team. The ideal candidate will have a strong background...
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Head of EU Regulatory Compliance
20 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAs Head of EU Regulatory Compliance, you will be responsible for ensuring that all regulatory requirements are met for our clinical trials in EU/ROW. This includes developing and implementing EU/ROW strategies, collaborating with CROs and internal stakeholders, and preparing and submitting regulatory documents.You will represent RA in Clinical Trial Teams...
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Copenhagen, Copenhagen, Denmark Coinify Aps Full timeCoinify ApS is a pioneering global virtual currency platform, offering cutting-edge solutions to businesses and individuals worldwide. Established in Copenhagen, Denmark in 2014, Coinify specializes in innovative individual currency trading, corporate brokerage, payment processing services, and enterprise solutions through the Coinify API.As we continue to...
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Regulatory Compliance Assistant
6 days ago
Copenhagen, Copenhagen, Denmark Gn Hearing AS Full timeRole Overview We are seeking a Regulatory Compliance Assistant to support our Director of Group Business Ethics & Compliance in an innovative, international environment at a global market leading tech company. This role involves assisting with preparing responses to internal and external information requests relevant to overall compliance function. The team...
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Copenhagen, Copenhagen, Denmark Coinify Aps Full timeJoin us at Coinify ApS, a leading global virtual currency platform, and become a part of our dynamic AML compliance team. We are seeking a Senior AML Officer to ensure regulatory compliance, manage AML/CFT risks, and lead key compliance projects.With a presence in over 150+ markets, Coinify empowers businesses and individuals to engage with financial...
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Product Regulatory Compliance Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are looking for a skilled Regulatory Affairs Manager to lead our product regulatory compliance efforts at Oresund Pharma ApS.This is a mid-senior level role that requires a deep understanding of regulatory requirements and processes. The ideal candidate will have a proven track record of managing complex regulatory projects, ensuring timely and...
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Global Regulatory Affairs Lead
20 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are looking for an exceptional individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring regulatory compliance and oversight for our clinical trials.In this role, you will represent RA in Clinical Trial Teams and...
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Regulatory Compliance Specialist
6 days ago
Copenhagen, Copenhagen, Denmark Kenvue Full timeJob DescriptionThe Senior Regulatory Affairs Specialist is responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims. They will manage the coordination and submission of regulatory applications for drugs, cosmetics, medical devices, and similar products.This role requires strong knowledge...
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IT Compliance Specialist with Regulatory Expertise
16 hours ago
Copenhagen, Copenhagen, Denmark Ubique Systems Full timeThe Ubique Systems IT Compliance Lead plays a critical role in defining and executing validation strategies for the development and implementation of our Non-GxP SaaS solution, the Genetics Analysis Platform. This involves ensuring that all systems are in compliance with relevant internal and external regulatory requirements.Key Responsibilities:Developing...
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Device Compliance and Regulatory Specialist
21 hours ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeAt Radiobotics, we believe that quality assurance and regulatory compliance are essential to delivering high-quality medical devices. As a regulatory affairs expert, you will play a vital role in ensuring our products meet the highest standards of quality and safety.In this role, you will work closely with the development team to drive product release...
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Regulatory Compliance Specialist
17 hours ago
Copenhagen, Copenhagen, Denmark Corti Full timeJob DescriptionWe are seeking a highly skilled Quality and Regulatory Affairs Manager to join our team. In this role, you will be responsible for ensuring that our products and services meet the highest standards of quality and compliance.Develop and maintain quality and risk management systems to ensure compliance with relevant regulations and...
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Regulatory Affairs Lead
6 days ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeJob SummaryThis role is an excellent opportunity for a seasoned Regulatory Affairs professional to lead regulatory projects both locally and globally. The ideal candidate will have a strong background in regulatory compliance, excellent communication skills, and the ability to work effectively in a fast-paced environment.The selected candidate will be...
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Regulatory Compliance Manager
21 hours ago
Copenhagen, Copenhagen, Denmark Danske Bank Full timeWe are looking for a Risk and Compliance Advisor to join our Business Data Protection team. The ideal candidate will have a strong understanding of regulatory requirements and a proven track record of implementing effective risk management strategies.The successful candidate will be responsible for identifying and mitigating risks associated with data...
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Global Regulatory Compliance Manager
6 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeOresund Pharma is seeking a Regulatory Affairs Manager to lead our product registration efforts globally. As a key member of our Regulatory department, you will ensure the successful delivery of regulatory plans aligned with business priorities.Key Responsibilities:Oversee the regulatory lifecycle management of our product portfolio.Ensure product compliance...
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Senior Regulatory Compliance Manager
6 days ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with global and local regulations.Collaborate with cross-functional teams, including Global Regulatory Affairs, Supply Chain, QA, Market Access, Marketing, and Medical.Communicate complex regulatory information to Health Authorities and internal stakeholders.Provide high-quality...
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Chief Regulatory Compliance Officer
4 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeRole OverviewThe Chief Regulatory Compliance Officer will be responsible for driving proactive compliance to protect Novo Nordisk's global license to operate. This role involves ensuring chemicals compliance and reducing environmental impact from both products and production.About the TeamYou will join a highly skilled specialist team in the Nature and...
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Head of Regulatory Compliance Denmark
6 days ago
Copenhagen, Copenhagen, Denmark SEB group Full timeWe are seeking an experienced Compliance Expert to join our team in Denmark. As a key member of our global Group Compliance function, you will play a vital role in ensuring that our operations are compliant with relevant laws and regulations.About the Role:You will be responsible for developing and implementing effective compliance strategies to meet...
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Compliance Expert Lead
6 days ago
Copenhagen, Copenhagen, Denmark Eurodollar Full timeCompany OverviewWe are a leading fintech company, Eurodollar, based in the Capital Region of Denmark. Our mission is to create innovative financial products onchain, leveraging our expertise in traditional finance, decentralized finance, and blockchain technology.Job DescriptionWe are seeking a highly skilled Compliance Expert to lead our compliance function...
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Regulatory Compliance Expert
2 days ago
Copenhagen, Copenhagen, Denmark AIP Management Full timeJob DescriptionThe role of a Compliance Officer (Manager level) at AIP Management involves taking responsibility for further developing and strengthening the general compliance framework. This includes supporting the organisation in its day-to-day business from a regulatory perspective, attending to ad-hoc requests, and ensuring a high standard of regulatory...