Director of Regulatory Affairs and Project Leadership
5 days ago
We 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 the clinical trial submissions in EU/ROW.
You will be responsible for representing EU/ROW in the Global Regulatory Team(s), acting as EU/ROW regulatory lead for assigned projects, and leading the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc. Additionally, you will plan, prepare, and lead EMA or national Scientific Advice procedures as relevant, evaluate regulatory risks, and recommend mitigation strategies to cross-functional teams and management.
Key Responsibilities- Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
- Represent EU/ROW in the Global Regulatory Team(s).
- Act as EU/ROW regulatory lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW strategy.
- Lead the preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, etc.
- Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
- Evaluate regulatory risks and recommend mitigation strategies to the cross-functional teams and management.
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Regulatory Affairs Project Director
5 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
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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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Director, EU/ROW Regulatory Affairs
6 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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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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Global Regulatory Affairs Project Lead
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Global Regulatory Affairs Leader
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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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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 timeAbout GenmabGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. We leverage translational research and data sciences to develop next-generation antibody technology platforms, including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced...
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