Regulatory Affairs Director

We are seeking a skilled and experienced Regulatory Affairs Director to join our team at Genmab A/S. As a key member of our Regulatory Affairs CMC team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of...

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...

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 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...

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...

About the RoleWe're expanding our team and seeking a seasoned Regulatory Affairs Associate Director - Biologics to join our Regulatory Affairs CMC team. As a Team Lead, you will lead a sub-team while actively contributing to regulatory projects. Your experience in developing and executing CMC strategies, interacting with health authorities, and ensuring...

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...

Job DescriptionThe position is responsible for developing and executing global regulatory strategies for biological products during early and late stage development, and lifecycle. This includes planning, reviewing, and preparing CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages. The...

About 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...

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...

Job Description Summary LOCATION: Copenhagen, DenmarkROLE TYPE: Hybrid working (3 days per week in the office) As a member of the Regulatory Affairs (RA) team in Copenhagen, you will get the opportunity to work in a dynamic, agile team who has a common goal to bring our medicines to patients. We are looking for a Regulatory Affairs Manager or...

We are seeking a highly experienced Regulatory Publisher & Submission Manager to join our Regulatory Affairs Team in Copenhagen or Malta.As a key member of our team, you will be responsible for:Regulatory publishing: compiling, formatting, and validating regulatory submissions in eCTD.System implementation: playing a key role in the implementation of our new...

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...

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...

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...

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 innovative and rooted in science, we believe that being...

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...

We are looking for a new colleague to join our Regulatory department. Oresund Pharma is seeking a dedicated and experienced Regulatory Affairs Manager; in this role you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a product portfolio following regulatory requirements and commercial demands. As a...

Job SummaryThis role is an excellent opportunity for a seasoned Regulatory Affairs professional to lead regulatory projects both locally and globally. The ideal candidate will have a strong background in regulatory compliance, excellent communication skills, and the ability to work effectively in a fast-paced environment.The selected candidate will be...

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...

About Our Ideal CandidateWe are looking for a seasoned professional with a strong background in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.The ideal candidate will have prior experience leading health authority meetings with the EMA or other health authorities, a good...