Director, EU/ROW Regulatory Affairs

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Team

Our 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 requirements and enables an integrated global clinical development and commercial strategy.

The ideal candidate will have significant experience in proactively planning and implementing complex clinical submission strategies, as well as leading teams of regulatory professionals. A strong understanding of drug development and EU regulatory mechanisms is essential, with expertise in expedited development pathways such as orphan drug designation and PRIME designation.

You will be responsible for developing and implementing global regulatory strategies for assigned projects, leading or being responsible for planning and implementation of regional regulatory procedures, and representing Regulatory Affairs across Genmab committees as indicated.

Responsibilities

  • Develop and implement global regulatory strategies for assigned projects
  • Lead or be responsible for planning and implementation of regional regulatory procedures (e.g., clinical trial applications, marketing applications, label extensions)
  • Represent Regulatory Affairs across Genmab committees as indicated


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the JobWe are seeking a highly motivated and self-driven individual to lead the development and execution of the EU/ROW regulatory strategy for assigned projects. As a Senior Regulatory Affairs Manager, you will be responsible for representing RA in the Clinical Trial Teams and ensuring oversight and progress of multiple clinical trial submission...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    The 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 ...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About 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...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Senior 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking an experienced Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. In this role, you will be responsible for leading the development and execution of the EU/ROW regulatory strategy for assigned projects.Key ResponsibilitiesAct as EU/ROW regulatory lead and EMA contact person for assigned...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Role 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About UsWe are a fast-growing, dynamic company dedicated to transforming the lives of people with cancer and other serious diseases through Knock-Your-Socks-Off (KYSO) antibody medicines. Our core purpose guides our unstoppable team to strive towards improving patient lives through innovative and differentiated antibody therapeutics.The Role and DepartmentIn...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab OverviewGenmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics. With a strong focus on translational research and data sciences, we have developed next-generation antibody technology platforms and built a pipeline of promising candidates.About the JobWe...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Job 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...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    We 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    As 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleThis is an exciting opportunity 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 the success of our clinical trials in EU/ROW.In this role, you will be responsible for providing regulatory expertise and...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About 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...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Job 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...