Global Regulatory Compliance Manager
3 days ago
Oresund 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 with regulations of relevant countries/regions.
- Prepare, review, and compile regulatory submissions.
- Create product information (SmPC, labelling, and patient leaflets).
- Monitor and set timelines for product maintenance, variations, and renewal approvals.
- Stay current with national and international legislation, guidelines, and customer practices.
- Maintain relationships and lines of communication with local competent regulatory health authorities.
- A strong scientific background, e.g., an MSc in Pharmaceutical Science, Biology, Healthcare Sciences, or similar.
- Ideal experience includes at least 5 years of work with regulatory activities, including Labelling, CMC, and/or other relevant aspects.
- Proficiency in MS 365.
- A proactive working approach.
- Ability to work well with deadlines and excellent attention to detail.
- A team player with demonstrated ability to manage and coordinate tasks across professions, including collaboration with diverse internal and external stakeholders.
- Danish or Nordic native language skills and fluency in English.
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Senior Regulatory Compliance Manager
3 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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Global Regulatory Expert
5 days ago
Copenhagen, Copenhagen, Denmark Pandora AS Full timePandora A/S, a world-renowned jewellery company, is seeking a highly skilled Global Regulatory Expert to join its Global Compliance team. The ideal candidate will have a strong background in regulatory compliance, with minimum five years of relevant experience.In this role, you will be responsible for designing and developing Pandora's global compliance...
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Global Regulatory Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeAbout the RoleIn this critical position, you will play a key role in driving regulatory strategy and ensuring compliance with global and local regulations. You will collaborate closely with internal stakeholders, including Global Regulatory Affairs, Supply Chain, QA, Market Access, Marketing, and Medical.The responsibilities of this role include leading...
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Regulatory Compliance Specialist
6 days ago
Copenhagen, Copenhagen, Denmark CareerArc Full timeJob SummaryWe are looking for a Senior Counsel, Regulatory Affairs to join our Global Regulatory Affairs team. As a key member of the team, you will play a critical role in facilitating the strategic development of our open banking business in Europe. The ideal candidate will have a proven track record of success in legal practice in fields drawn from...
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Head of Regulatory Compliance Denmark
3 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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Global Product Compliance Manager
2 days ago
Copenhagen, Copenhagen, Denmark Monta Full timeMonta is a rapidly growing company revolutionizing the EV charging experience. We are looking for a skilled Global Product Compliance Manager to join our team and help us shape the future of product localization.This role involves driving product-market fit in existing markets and ensuring compliance when expanding into new markets. If you have a passion for...
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Regulatory Compliance Specialist
3 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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Regulatory Compliance Assistant
4 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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Global Regulatory Affairs Leader
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleWe are seeking a highly experienced Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization. As an integral part of our team, you will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW.In this role, you will represent RA in the Clinical...
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Head of Regulatory Compliance
5 days ago
Copenhagen, Copenhagen, Denmark Brinch & Partners Full timeAbout the PositionWe are looking for a dynamic leader to drive our Product Stewardship program, ensuring compliance with global chemical regulations and fostering strategic partnerships with key stakeholders.The successful candidate will have a proven track record in Product Stewardship, chemical regulation, and hazard communication, with a strong ability to...
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Chief Regulatory Compliance Officer
2 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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Global Compliance Manager
5 days ago
Copenhagen, Copenhagen, Denmark Pandora AS Full timeDo you want to be part of a global compliance team in the biggest jewellery company in the world? Do you bring solid experience in compliance management and advisory? If so, we want to hear from you. We are looking for a Global Compliance Manager who can take lead driving the compliance agenda across Pandora. As a Global Compliance Manager you will be part...
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Regulatory Manager
5 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 Compliance Professional
7 days ago
Copenhagen, Copenhagen, Denmark Lunar Denmark Full timeAbout UsLunar Denmark is a fintech company that's democratizing the power of money and changing the way we all bank, pay, and invest. Our mission is to challenge the status quo and create a better future for our customers.We're not just a tech company or a bank – we're both. We've broken free from traditional categories and are creating a new way of doing...
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Regulatory Compliance Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeAre you a motivated and results-driven individual looking for a new challenge? We are seeking a Manufacturing Quality Control Expert to join our team at Lundbeck A/S, H.Key Responsibilities:Quality System Development: Design and implement quality systems to ensure compliance with GMP/GDP regulations.Auditing and Compliance: Conduct regular audits to identify...
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Chief Regulatory Officer
2 days ago
Copenhagen, Copenhagen, Denmark Tbwa ChiatDay Inc Full timeRole OverviewThe VP of Public Policy and Regulatory Affairs will lead the development of AstroPay's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business goals. This role will oversee the company's engagement with regulatory bodies, shape public policy initiatives, and ensure seamless...
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Copenhagen, Copenhagen, Denmark Nordea Full timeAbout This OpportunityThis is a chance to make a meaningful contribution to Nordea's compliance with the legal framework.You will be working closely with regulators and managing regulatory changes, which are of key importance to Nordea.Responsibilities include:Monitoring regulatory changes relevant to business areas or group functionsConducting assessments...
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Regulatory Affairs Manager
3 days ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeJob Description Summary LOCATION: Copenhagen, DenmarkROLE TYPE: Hybrid working (3 days per week in the office) As a member of the Regulatory Affairs (RA) team in Copenhagen, you will get the opportunity to work in a dynamic, agile team who has a common goal to bring our medicines to patients. We are looking for a Regulatory Affairs Manager or...
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Compliance Programme Manager
3 days ago
Copenhagen, Copenhagen, Denmark Pandora AS Full timeJob DescriptionWe are looking for a highly motivated and experienced Compliance Programme Manager to lead our global compliance programme. As a key member of our team, you will be responsible for driving our compliance agenda and ensuring that we maintain the highest standards of integrity.Main ResponsibilitiesDevelop and implement effective compliance...
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Global Compliance Project Coordinator
3 days ago
Copenhagen, Copenhagen, Denmark Saxo Group Full timeWe are seeking a skilled Global Compliance Project Coordinator to join our AML team at Saxo Group. As a key member of our team, you will be responsible for coordinating AML projects and supporting the development of strategies to prevent financial crime.About the RoleThis role involves working closely with cross-functional teams to deliver AML projects and...