Global Regulatory Compliance Manager
4 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
4 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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Regulatory Compliance Manager
4 hours 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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Global Regulatory Expert
6 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
4 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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Global Regulatory Manager
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Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeOresund Pharma ApS is a dynamic and ambitious company seeking a talented Global Regulatory Manager to join our Regulatory department.In this role, you will be responsible for ensuring that our products comply with regulatory requirements and commercial demands worldwide. This includes managing regulatory submissions, establishing relationships with...
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Regulatory Compliance Specialist
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Head of Regulatory Compliance Denmark
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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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Compliance Officer: Regulatory Expertise Required
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Chief Regulatory Compliance Officer
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Product Regulatory Compliance Specialist
23 hours 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 Compliance Manager
6 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 Compliance Expert
2 hours 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...
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Global Regulatory Expert
4 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeUnlock the Potential of Regulatory AffairsGenmab A/S is seeking a highly experienced and skilled Global Regulatory Expert to join its team. As a key member of the Global Regulatory Affairs organization, you will play a crucial role in shaping the company's regulatory strategies and ensuring the successful execution of global submissions.About the RoleThe...