Senior Manager EU Regulatory Affairs

Genmab is a pioneering biotechnology company with a core purpose to transform the lives of patients through innovative antibody therapeutics.We're looking for an experienced and passionate leader to be part of our Global Regulatory Affairs organization. In this role, you will develop global strategies to advance Genmab's portfolio of development pipeline...

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...

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...

At Genmab, we're committed to creating extraordinary futures together by developing innovative antibody products and therapies that change the lives of patients. As our Senior Manager EU/ROW Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy and ensuring compliance with EU and ROW regulations.As a key member of our Global...

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...

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...

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...

Transform Lives through Innovative Cancer TreatmentWe are 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...

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...

Get AI-powered advice on this job and more exclusive features. Senior Business Development Consultant at Black Swans Exist Director of Regulatory Affairs Are you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health,...

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...

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...

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...

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. Our passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and...

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...

About the RoleAt Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and...

Black Swans Exist, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a seasoned Director of Regulatory Affairs to spearhead their global regulatory strategies.About the RoleIn this high-impact position, you will drive the development and approval of innovative biologics, combination drug-device...

Radiometer Danmark/Danaher is proud to work at the forefront of diagnostic innovation. Our shared purpose unites over 4000 employees worldwide in a pursuit to improve patient care through technology and solutions.We are seeking an exceptional individual to join our Global Regulatory Affairs team as Senior Manager, RA Processes, Systems and Tools.As part of...

EU Regulatory Body Consultancy ServicesNTU International A/S is seeking a highly experienced expert to provide consultancy services to the European Union's regulatory body. The project focuses on strengthening the nuclear safety and radioprotection regulatory infrastructure of the Egyptian Nuclear and Radiological Regulatory Authority (ENRRA).The key...

We are seeking a highly motivated and experienced Regulatory Project Manager to join our team at Genmab. As an Associate Director, Global Regulatory Affairs Project Lead, you will be responsible for ensuring regulatory compliance and oversight for our clinical trials, as well as developing and executing EU/ROW strategies for assigned projects.In this role,...