Regulatory Affairs Specialist
1 week ago
This is a mid-senior level full-time position requiring a strong understanding of CMC development and regulatory affairs.
- Coordinate inputs across departments and external stakeholders
- Manage risk proactively using scientific and operational insight
- Prepare and facilitate technical project meetings
- Project management experience in biotech or pharma (CMC focus essential)
- Scientific background — MSc or higher in life sciences, biochemistry, biotechnology, or similar
- Excellent communication and coordination skills
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Regulatory Affairs Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Amoria Bond Full timeRegulatory Affairs Specialist (MedTech) – 6 Month Contract | CopenhagenOn behalf of an exciting client in the medical device industry, we are looking for a Regulatory Affairs Specialist for a 6-month freelance assignment based in Copenhagen.You will support regulatory activities for innovative medical devices, ensuring compliance with MDR and other...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe're dedicated to creating life-changing treatments at Genmab, and we're seeking a highly skilled Biopharmaceuticals Regulatory Affairs Specialist to join our Regulatory Affairs CMC team.Director/Associate Director, Global Regulatory Affairs - CMCIn this critical role, you will be responsible for providing regulatory CMC input to support worldwide...
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Regulatory Affairs Senior Counsel
21 hours ago
Copenhagen, Copenhagen, Denmark MasterCard Full timeAbout the Role\As a Senior Counsel, Regulatory Affairs, you will be part of Mastercard's Global Regulatory Team, responsible for facilitating the strategic development of our open banking business in Europe. This role is based in Denmark and will support Mastercard Open Banking Services EU (MCOBS EU) subsidiary that holds PIS and AIS regulatory license in...
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Regulatory Affairs Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are seeking a dedicated and experienced Regulatory Affairs Manager.As part of our team, you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a global product portfolio following regulatory requirements and commercial demands.As Regulatory Affairs Manager, you will be responsible for your own portfolio...
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Regulatory Affairs Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are seeking a dedicated and experienced professional to join our Regulatory department as a Regulatory Affairs Manager. This role will be responsible for maintaining and developing a product portfolio following regulatory requirements and commercial demands.Key ResponsibilitiesEnsure timely delivery of regulatory plans in alignment with business...
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Regulatory Affairs Strategist
2 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab A/S is dedicated to creating life-changing antibody therapeutics for patients with cancer and other serious diseases. As a Regulatora Affairs Strategist in our Global Regulatory Affairs organization, you will play a key role in shaping the regulatory strategy for our products.Your primary responsibility will be to support the Global Regulatory Lead...
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Regulatory Affairs Expert for Medical Devices
18 hours ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeWe are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We believe in integrity, transparency, and open communication. Our vision is to augment routine X-rays of the musculoskeletal system, enabling non-specialists to read radiology images assisted by our products, and ensuring patients have access to immediate expert-level evaluation...
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Regulatory Affairs Leader
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking an experienced leader to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs Strategy-EU/RoW. This role will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products.The ideal candidate will have a strong...
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Regulatory Affairs Manager
1 week ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeInnovative solutions for a better tomorrowRadiometer Danmark / Danaher is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We strive to make a difference in people's lives by providing cutting-edge technology and solutions.The Senior Manager, RA Processes, Systems and Tools plays a crucial role in driving process...
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Regulatory Affairs Coordinator
2 days ago
Copenhagen, Copenhagen, Denmark IQVIA Argentina Full timeJob Title: Regulatory Affairs CoordinatorIQVIA Argentina is seeking a highly skilled Regulatory Affairs Coordinator to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, providing training and support to sites, and collaborating with the study team to track the progress of assigned studies.Key...
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Director of Regulatory Affairs
1 week ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeGet AI-powered advice on this job and more exclusive features.Senior Business Development Consultant at Black Swans ExistDirector of Regulatory AffairsAre you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a...
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Regulatory Affairs Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeWe're Novo Nordisk A/S, a global leader in diabetes care and biopharmaceuticals. Our mission is to improve the lives of millions of people around the world. To achieve this, we need talented individuals who share our passion for innovation and excellence.We're looking for a skilled Regulatory Affairs Specialist - Chemicals to join our Nature and Chemicals...
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Regulatory Affairs Director
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the PositionWe are seeking a highly skilled Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the opportunity to utilize your expertise to drive regulatory compliance and quality in clinical trials.ResponsibilitiesDrive regulatory compliance and quality in...
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Global Regulatory Affairs Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full timeSandoz International GmbH is a leading generic and biosimilar medicines company, committed to improving access to high-quality, low-cost medicines for patients worldwide. We are seeking a highly motivated Global Regulatory Affairs Manager to join our LCM Product team.In this role, you will be responsible for managing global regulatory affairs, including...
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Regulatory Affairs Consultant
2 days ago
Copenhagen, Copenhagen, Denmark Prolific Xpert Full timeThe Regulatory Affairs Consultant will play a crucial role in ensuring that our organization adheres to national and international legislation and guidelines regarding compliance and audits.Key DeliverablesDevelop policies and procedures for compliance and risk managementConduct regular training sessions for employees on compliance and risk...
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CMC Regulatory Affairs Specialist
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWhy Join UsGenmab offers a unique opportunity to work with a talented team of professionals who share a passion for innovation and excellence. As a member of our Regulatory Affairs CMC team, you will have the chance to develop and execute global regulatory CMC strategies, collaborate with cross-functional teams, and prepare CMC documentation for various...
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Senior Counsel, Regulatory Affairs
1 week ago
Copenhagen, Copenhagen, Denmark MasterCard Full timeSenior Counsel, Regulatory AffairsSenior Counsel, Regulatory AffairsApply locations Copenhagen, Denmark time type Full time posted on Posted 22 Days Ago job requisition id R-242297Our PurposeMastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where...
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Senior Counsel, Regulatory Affairs
22 hours ago
Copenhagen, Copenhagen, Denmark MasterCard Full timeSenior Counsel, Regulatory Affairs Senior Counsel, Regulatory Affairs Apply locations Copenhagen, Denmark time type Full time posted on Posted 22 Days Ago job requisition id R-242297 Our Purpose Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy...
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Global Regulatory Affairs Manager
14 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are looking for an exceptional Global Regulatory Affairs Manager to join our team. This individual will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects, representing RA in the Clinical Trial Teams, and ensuring progress of multiple clinical trial submission activities.The Role & DepartmentThis position...
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Senior Counsel, Regulatory Affairs
5 days ago
Copenhagen, Copenhagen, Denmark MasterCard Full timeOur PurposeMastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart, and accessible. Our technology and innovation, partnerships,...