Regulatory Affairs Professional
6 days ago
Radiometer Danmark/Danaher is a leading company in diagnostics, partnering with customers across the globe to help them solve their most complex challenges. We're looking for a highly skilled Regulatory Affairs Professional to join our team and contribute to our mission.
The successful candidate will possess an MSc in Engineering, Pharmacy, Biology, Biochemistry or similar, along with profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/Diagnostics.
Your key responsibilities will include participating in and driving smaller projects in the RA/QA function, guiding the organization during External Audits, and planning, facilitating, and conducting training of the organization.
- Key Requirements:
- MSc in Engineering, Pharmacy, Biology, Biochemistry or similar
- Profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/Diagnostics
- Min. 5 years of in-depth knowledge and experience with applicable standards and regulatory requirements (ISO 13485, IVDD/IVDR, MDR, and FDA legislation)
- Excellent communication and stakeholder management skills
- Master spoken and written English and Danish language skills
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Regulatory Affairs Professional
21 hours ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeOresund Pharma ApS is a Nordic-based privately owned specialty pharmaceutical company focusing on marketing value-added products in the European countries.We are seeking a dedicated and experienced Regulatory Affairs Manager to join our team. As a key member of our Regulatory department, you will be responsible for Oresund Pharma's products worldwide,...
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Regulatory Affairs Manager
4 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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Regulatory Affairs Project Director
6 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionWe are seeking an experienced and skilled professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for managing the regulatory aspects of our clinical trials in EU/ROW, including preparing and submitting regulatory documents, leading EMA or national Scientific Advice...
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Regulatory Affairs Director
3 hours ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark/Danaher is proud to work at the forefront of diagnostic innovation. Our shared purpose unites over 4000 employees worldwide in a pursuit to improve patient care through technology and solutions.We are seeking an exceptional individual to join our Global Regulatory Affairs team as Senior Manager, RA Processes, Systems and Tools.As part of...
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Regulatory Affairs Lead
4 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 Affairs Leader
22 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the JobWe are seeking a seasoned Regulatory Affairs professional to join our Global Regulatory Affairs team. As a Senior Director, you will be responsible for the development and implementation of EU/ROW regulatory strategies for Genmab's programs across all stages of development. You will work closely with cross-functional teams to ensure an optimal...
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Director, EU/ROW Regulatory Affairs
18 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the TeamOur Global Regulatory Affairs team is responsible for ensuring that Genmab's programs meet regulatory requirements and are developed and implemented in accordance with EU and international regulations. We work closely with cross-functional teams to ensure that our programs are developed and implemented in a way that meets regulatory...
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Regulatory Affairs Director
4 days ago
Copenhagen, Copenhagen, Denmark Pandora AS Full timeAbout the JobPandora A/S is seeking a highly motivated and experienced Regulatory Affairs Director to lead our global regulatory affairs function. As a key member of our team, you will be responsible for ensuring that we maintain the highest standards of regulatory compliance and integrity.Main ResponsibilitiesDevelop and implement effective regulatory...
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Pharmaceutical Regulatory Affairs Specialist
7 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeRegulatory Affairs Document SpecialistWe are seeking a highly skilled Regulatory Affairs Document Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6,...
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Regulatory Affairs Specialist
4 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 ensuring the compliance of Oresund Pharma's products with regulatory requirements worldwide.Key Responsibilities:Develop and maintain a product portfolio following regulatory requirements and commercial...
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Senior Regulatory Affairs Manager
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Copenhagen, Copenhagen, Denmark Macure Pharma Full timeWe are seeking a highly experienced Regulatory Publisher & Submission Manager to join our Regulatory Affairs Team in Copenhagen or Malta.As a key member of our team, you will be responsible for:Regulatory publishing: compiling, formatting, and validating regulatory submissions in eCTD.System implementation: playing a key role in the implementation of our new...
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Copenhagen, Copenhagen, Denmark Genmab Full timeRole OverviewWe are seeking a highly skilled and experienced professional to join our Global Regulatory Affairs organization as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of...
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Regulatory Affairs Director
3 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are seeking a skilled and experienced Regulatory Affairs Director to join our team at Genmab A/S. As a key member of our Regulatory Affairs CMC team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of...
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Regulatory Affairs Manager
4 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are looking for a new colleague to join our Regulatory department. Oresund Pharma is seeking a dedicated and experienced Regulatory Affairs Manager; in this role you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a product portfolio following regulatory requirements and commercial demands. As a...
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Global Regulatory Affairs Leader
6 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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Senior Counsel, Regulatory Affairs
7 days ago
Copenhagen, Copenhagen, Denmark CareerArc Full timeOur Purpose Mastercard 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...
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Strategic Regulatory Affairs Leader
2 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeTransform Lives through Innovative Cancer TreatmentWe are 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...
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Global Regulatory Affairs Project Lead
6 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to developing groundbreaking antibody products that transform the lives of patients suffering from cancer and other serious diseases. Our team is driven by a passion for innovation and a dedication to pushing the boundaries of what's possible.The Role & DepartmentWe're seeking an experienced Regulatory Affairs professional to join...
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Regulatory Affairs Director
6 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob DescriptionThe position is responsible for developing and executing global regulatory strategies for biological products during early and late stage development, and lifecycle. This includes planning, reviewing, and preparing CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages. The...
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Senior Regulatory Affairs Counsel
7 days ago
Copenhagen, Copenhagen, Denmark CareerArc Full timeCompany OverviewCareerArc powers economies and empowers people in 200+ countries and territories worldwide. We're helping build a sustainable economy where everyone can prosper. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses, and governments realize their greatest...