Associate Director Regulatory Strategy
6 days ago
The Associate Director, Global Regulatory Affairs Project Lead will play a critical role in our Global Regulatory Affairs organization. As an expert in regulatory affairs, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.
You will lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc., and plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
Responsibilities:- Represent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of multiple clinical trial submission activities.
- Lead the preparation of strategic regulatory documents.
- Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
The chosen candidate may also be allocated as EU/ROW regulatory strategy lead to one or multiple compounds in early development and provide regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team.
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Director of EU and ROW Regulatory Strategy
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are looking for a skilled professional to fill the position of (Associate) Director, Global Regulatory Affairs Project Lead at Genmab.About the RoleThis role involves collaborating with the Global Regulatory Team to develop and execute EU/ROW regulatory strategies for our compoundsYou will represent RA in Clinical Trial Teams and ensure regulatory...
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Associate Director, EU/ROW Regulatory Lead
1 week 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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Associate Director, EU/ROW Regulatory Lead
6 days 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 . Associate Director, EU/ROW Regulatory Lead page is loaded Associate Director, EU/ROW Regulatory Lead Apply locations Copenhagen time type Full time posted on ...
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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.Director/Associate Director, Global Regulatory Affairs - CMCAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering...
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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 Director/Associate Director, Global Regulatory Affairs - CMC At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that...
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Regulatory Affairs Director
2 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products that change the lives of patients and the future of cancer treatment.The Regulatory Affairs CMC team is evolving and we are therefore looking for a Director/Associate Director to join our dynamic team. The successful candidate will be responsible...
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EU/ROW Regulatory Strategy Director
14 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleAs a Senior Director, Regulatory Affairs Strategy-EU/RoW, you will join our Global Regulatory Affairs organization and assume responsibility for EU/ROW regulatory strategy for assigned program. You will manage a group of Regulatory Strategists with EU/ROW responsibilities for Genmab's programs across all stages of development.The successful...
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Regulatory Strategy Lead
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab is committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.We're seeking a Regulatory Strategy Lead to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for operational and strategic regulatory CMC input to support worldwide development...
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Director of Regulatory Affairs
6 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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 innovative and rooted in science, we believe that being...
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Regulatory Affairs Leader
6 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob OverviewGenmab A/S is seeking a highly motivated and experienced Regulatory Affairs professional to join our Global Regulatory Affairs team as an Associate Director, EU/ROW Regulatory Lead. The successful candidate will be responsible for representing RA in the Clinical Trial Teams, ensuring regulatory oversight and progress of multiple clinical trial...
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Global Regulatory Strategy Director
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleThe 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 your local HR department.Key ResponsibilitiesRepresent RA in the Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure regulatory oversight and progress...
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Global Regulatory Expertise Leader
6 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is an international biotechnology company dedicated to improving patient lives through innovative antibody therapeutics. We're seeking an experienced professional to fill the position of (Associate) Director, Global Regulatory Affairs Project Lead.About the RoleThis role requires collaboration with the Global Regulatory Team to develop and execute...
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Regulatory Affairs Manager
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeRole SummaryAs an Associate Director, Global Regulatory Affairs Project Lead, you will be responsible for ensuring regulatory compliance and oversight of multiple clinical trial submissions. You will work closely with the CRO and internal stakeholders to develop and execute EU/ROW regulatory strategies for assigned projects.This role requires strong project...
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Regulatory Affairs Project Lead Position
6 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we are committed to pushing the boundaries of cancer treatment through innovative therapies. As a key member of our Global Regulatory Affairs organization, you will play a vital role in developing and executing EU/ROW regulatory strategies for our compounds.">The Role & DepartmentYou will join our dynamic team as an (Associate) Director, Global...
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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/RoWAt 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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Global Regulatory Affairs Project Lead
6 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob OverviewWe are seeking a highly skilled and experienced Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab. In this role, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.You will work closely with the...
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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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Senior Director, Regulatory Affairs Strategy-EU/RoW
21 hours ago
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...