EU/ROW Regulatory Strategy Lead
19 hours ago
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. Our passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
To help develop and deliver novel antibody therapies to patients, we've formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, our vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
As our Senior Manager EU/ROW Regulatory Affairs, you'll be responsible for representing RA in clinical trial teams, ensuring regulatory oversight and progress of multiple clinical trial submission activities, and representing EU/ROW in the Global Regulatory Team(s). You'll act as EU/ROW Regulatory Lead for assigned projects and be responsible for developing and executing EU/ROW regulatory strategies, leading the preparation of strategic regulatory documents, planning, preparing, and leading EMA or national scientific advice procedures as relevant, evaluating regulatory risks, and recommending mitigation strategies.
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Senior Regulatory Lead EU/ROW
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob Description:The Senior Regulatory Lead EU/ROW will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in the EU/ROW region. This role will represent RA in the Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Represent...
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Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is a pioneering biotechnology company with a core purpose to transform the lives of patients through innovative antibody therapeutics.We're looking for an experienced and passionate leader to be part of our Global Regulatory Affairs organization. In this role, you will develop global strategies to advance Genmab's portfolio of development pipeline...
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Associate Director, EU/ROW Regulatory Lead
23 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com . Associate Director, EU/ROW Regulatory Lead page is loaded Associate Director, EU/ROW Regulatory Lead Apply locations Copenhagen time type Full time ...
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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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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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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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Senior Manager EU Regulatory Affairs
19 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAs our Senior Manager EU/ROW Regulatory Affairs, you'll be responsible for ensuring that our regulatory affairs functions are operating effectively and efficiently. This includes representing RA in clinical trial teams, ensuring regulatory oversight and progress of multiple clinical trial submission activities, and representing EU/ROW in the Global...
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Director of Regulatory Strategy
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to transforming the lives of patients through innovative cancer treatments. Our Global Regulatory Affairs organization is seeking a highly motivated and experienced individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead.This role will involve representing RA in Clinical Trial Teams and working...
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Head of EU Regulatory Compliance
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAs Head of EU Regulatory Compliance, you will be responsible for ensuring that all regulatory requirements are met for our clinical trials in EU/ROW. This includes developing and implementing EU/ROW strategies, collaborating with CROs and internal stakeholders, and preparing and submitting regulatory documents.You will represent RA in Clinical Trial Teams...
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Regulatory Affairs Leader
7 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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Associate Director Regulatory Strategy
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob Overview:Genmab is seeking a highly motivated and experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization. As the Global Regulatory Compliance Officer, you will be responsible for ensuring that Genmab's products comply with regulatory requirements in the EU/ROW region.Key Responsibilities:Evaluate regulatory risks...
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Global Regulatory Affairs Lead
5 days 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 Director
5 days 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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Director, EU/ROW Regulatory Affairs
7 days 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
19 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're committed to creating extraordinary futures together by developing innovative antibody products and therapies that change the lives of patients. As our Senior Manager EU/ROW Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy and ensuring compliance with EU and ROW regulations.As a key member of our Global...
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Regulatory Project Manager
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are seeking a highly motivated and experienced Regulatory Project Manager to join our team at Genmab. As an Associate Director, Global Regulatory Affairs Project Lead, you will be responsible for ensuring regulatory compliance and oversight for our clinical trials, as well as developing and executing EU/ROW strategies for assigned projects.In this role,...
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Global Regulatory Expert
6 days 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...
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Associate Director of Global Regulatory Compliance
19 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeOur Regulatory Affairs organization plays a critical role in ensuring the successful development and approval of our innovative antibody products and therapies. As our Senior Manager EU/ROW Regulatory Affairs, you'll have the opportunity to make a significant impact on our regulatory strategy and compliance efforts.You'll work closely with cross-functional...
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Strategic Regulatory Affairs Leader
6 days 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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Head of EU and ROW Regulatory Affairs
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe're a fast-growing biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics.We're looking for an experienced and passionate leader to be part of our Global Regulatory Affairs organization. In this role, you will develop global strategies to advance Genmab's portfolio of development pipeline candidate drugs...