EU Regulatory Strategy Lead

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Opportunity

We are excited to announce an opportunity for a seasoned Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the chance to leverage your expertise to drive regulatory compliance and quality in clinical trials.

Key Responsibilities

  • Leverage your knowledge of regulatory guidelines and regulations to ensure compliance in clinical trials.
  • Develop and execute EU/ROW regulatory strategies for assigned projects.
  • Prepare and submit regulatory documents, such as Briefing Packages, ODDs, and PIPs.
  • Collaborate with cross-functional teams to ensure alignment and effective communication.

About Us

  • We are a global biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment.
  • We are committed to fostering a workplace culture that values diversity, equity, and inclusion.


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're dedicated to developing innovative antibody therapies that transform the lives of patients. Our passionate team of experts is committed to building extraordinary futures together, by pioneering cutting-edge treatments for serious diseases.The Role & Department We're seeking a highly skilled Regulatory Affairs Project Lead to join our Global...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Genmab A/S is a biotechnology company that aims to transform the lives of people with cancer and other serious diseases through innovative and differentiated antibody therapeutics. Our team has developed a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About the RoleGenmab is seeking an experienced Senior Manager/Associate Director to lead our Global Regulatory Affairs organization as EU/ROW Regulatory Lead. In this role, you will represent RA in Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.Key...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About the JobAs Associate Director, EU/ROW Regulatory Lead, you will play a critical role in Genmab's Global Regulatory Affairs organization. Your primary responsibility will be to lead the development and execution of EU/ROW regulatory strategies for assigned projects.Your Key ObjectivesDevelop and implement EU/ROW regulatory strategies to ensure compliance...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the JobThis is an exciting opportunity to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. As a key member of our team, you will play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of 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 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 ...


  • 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 AS Full time

    Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics. Our team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to create a proprietary pipeline including bispecific T-cell engagers,...


  • 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

    Senior 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job SummaryWe are seeking an experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. The successful candidate will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of clinical trial...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About the PositionWe are seeking an experienced Associate Director to join our Global Regulatory Affairs organization as EU/ROW Regulatory Lead. In this role, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects.Your Key AccountabilitiesDevelop and implement EU/ROW regulatory strategies to ensure compliance...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About YouWe are looking for a highly experienced Senior Director to join our Global Regulatory Affairs organization in the EU/ROW region. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.The successful...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionWe are seeking a highly experienced Senior Director to lead our Global Regulatory Affairs organization in the EU/ROW region. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.The successful...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Key ResponsibilitiesRepresent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of multiple clinical trial submission activities.Develop and execute the EU/ROW strategy for assigned projects.Lead the preparation of strategic regulatory documents, including Briefing Packages, ODDs, PIPs, etc.Plan, prepare and lead EMA or national...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are looking for a Senior Director to join our Global Regulatory Affairs organization in the EU/ROW region. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.The successful candidate will have...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking an experienced and skilled individual to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. You will act as the representative of RA on Clinical Trial Teams...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    ResponsibilitiesThe Senior Director will be responsible for the following:* Developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products* Managing multiple projects simultaneously, including clinical trial applications, marketing authorizations, and variations* Leading teams...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    About UsAt Black Swans Exist, we're passionate about revolutionizing microbiome-based therapies for women's reproductive health. Our mission is to develop innovative biologics and combination drug-device products that transform lives.The JobWe're seeking a highly experienced Director of Regulatory Affairs to lead our global regulatory strategies. As a key...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionWe are seeking a highly skilled and experienced Strategic Director of Regulatory Affairs to join our team at Genmab. In this role, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.You will provide strategic input and...