Senior Regulatory Affairs Manager
2 days ago
We 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 Submission Publishing Tool and ensuring its successful integration.
- Process optimization: identifying opportunities to streamline workflows and drive efficiency within Regulatory Affairs.
- Regulatory affairs: supporting submission processes for National, MRP, and DCP procedures, as well as regulatory lifecycle management and interactions with CMOs, external partners, and health authorities.
If you have experience in implementing or working with EDMS systems, your expertise will be highly valued in this role.
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Regulatory Affairs Manager
5 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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Regulatory Affairs Director
1 day 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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Director of Regulatory Affairs
7 hours 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 Exist Director of Regulatory Affairs Are 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,...
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Regulatory Affairs Manager
5 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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Global Regulatory Affairs Leader
7 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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Strategic Regulatory Affairs Leader
1 day 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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Senior Director of Global Regulatory Affairs
11 hours ago
Copenhagen, Copenhagen, Denmark Tbwa ChiatDay Inc Full timeJob Overview:The Senior Director of Global Regulatory Affairs will lead Tbwa Chiat/Day Inc's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business objectives. This role involves overseeing the company's engagement with regulatory bodies, shaping public policy initiatives, and ensuring seamless...
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Senior Manager Regulatory Compliance
24 hours ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark/Danaher is a leading company in diagnostic innovation, aiming to enhance global healthcare through technology and solutions. Our team consists of over 4000 employees worldwide who share a common purpose: improving patient care.We are currently seeking a highly skilled professional to join our Global Regulatory Affairs team as Senior...
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Regulatory Affairs Director
29 minutes ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleAt Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and...
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Regulatory Affairs Visionary
4 hours ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeBlack Swans Exist, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a seasoned Director of Regulatory Affairs to spearhead their global regulatory strategies.About the RoleIn this high-impact position, you will drive the development and approval of innovative biologics, combination drug-device...
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Regulatory Affairs Manager
4 hours ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeAbout RadiometerRadiometer is a leading manufacturer of in vitro diagnostic instruments and consumables, dedicated to improving global healthcare through reliable, fast, and easy patient diagnoses. Our vision is to improve patient lives by making accurate diagnoses possible.As a key member of our team, you will be responsible for driving process improvements...
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Regulatory Affairs Project Director
7 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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Global Regulatory Affairs Lead
3 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 Affairs Leader
2 days 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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Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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 rooted in...
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Regulatory Affairs Director
4 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the Role:The Associate Director Regulatory Strategy will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. This role will represent EU/ROW in the Global Regulatory Team(s) and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Develop...
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Regulatory Affairs Director
5 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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Regulatory Affairs Lead
5 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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Copenhagen, Copenhagen, Denmark Genmab AS Full timeSenior Director, Regulatory Affairs Strategy-EU/RoW At Genmab, we're 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...
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Regulatory Affairs Professional
2 days 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,...