Associate Director of Global Regulatory Compliance
5 days ago
Our Regulatory Affairs organization plays a critical role in ensuring the successful development and approval of our innovative antibody products and therapies. As our Senior Manager EU/ROW Regulatory Affairs, you'll have the opportunity to make a significant impact on our regulatory strategy and compliance efforts.
You'll work closely with cross-functional teams, including Clinical Trials, Compound Development, and Global Regulatory, to ensure that our regulatory plans are aligned with business objectives and that we're meeting our regulatory obligations. Your expertise will be invaluable in developing and executing EU/ROW regulatory strategies, and in providing guidance on procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team.
We're looking for someone with a strong background in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications. Prior experience leading health authority meetings with the EMA or other health authorities is essential, as well as a good understanding of drug development and EU regulatory procedures. Experience within oncology and/or I&I will be a plus, as will experience with PIPs and development and regulatory requirements in ROW markets.
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob OverviewWe are seeking an experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs team at Genmab A/S. The successful candidate will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing...
-
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 Workday@Genmab.com.Director/Associate Director, Global Regulatory Affairs - CMCAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering...
-
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...
-
Associate Director Regulatory Strategy
15 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThe Associate Director, Global Regulatory Affairs Project Lead will play a critical role in our Global Regulatory Affairs organization. As an expert in regulatory affairs, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.You...
-
Global Regulatory Affairs Lead
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob DescriptionThe Regulatory Affairs team at Genmab A/S is seeking an experienced professional to fill the role of Director/Associate Director, Global Regulatory Affairs. The successful candidate will be responsible for providing strategic regulatory guidance on CMC topics, collaborating with cross-functional peers, and planning and preparing CMC...
-
Regulatory Affairs Director
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob RoleThe Director/Associate Director, Global Regulatory Affairs will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.This role requires strong leadership and...
-
CMC and Global Regulatory Affairs Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the JobGenmab A/S is seeking an experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs team. The successful candidate will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization...
-
Associate Director, EU/ROW Regulatory Lead
5 days ago
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 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 ...
-
Associate Director, EU/ROW Regulatory Lead
20 hours ago
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 . Associate Director, EU/ROW Regulatory Lead page is loaded Associate Director, EU/ROW Regulatory Lead Apply locations Copenhagen time type Full time posted on ...
-
Director of Regulatory Affairs
1 day ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...
-
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...
-
Global Regulatory Expertise Leader
15 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is an international biotechnology company dedicated to improving patient lives through innovative antibody therapeutics. We're seeking an experienced professional to fill the position of (Associate) Director, Global Regulatory Affairs Project Lead.About the RoleThis role requires collaboration with the Global Regulatory Team to develop and execute...
-
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...
-
Director of EU and ROW Regulatory Strategy
11 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are looking for a skilled professional to fill the position of (Associate) Director, Global Regulatory Affairs Project Lead at Genmab.About the RoleThis role involves collaborating with the Global Regulatory Team to develop and execute EU/ROW regulatory strategies for our compoundsYou will represent RA in Clinical Trial Teams and ensure regulatory...
-
Global CMC Director
15 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab 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.We're looking for a Global CMC Director to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for operational...
-
Regulatory Affairs Manager
11 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeRole SummaryAs an Associate Director, Global Regulatory Affairs Project Lead, you will be responsible for ensuring regulatory compliance and oversight of multiple clinical trial submissions. You will work closely with the CRO and internal stakeholders to develop and execute EU/ROW regulatory strategies for assigned projects.This role requires strong project...
-
Global Regulatory Affairs Project Lead
18 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob OverviewWe are seeking a highly skilled and experienced Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab. In this role, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.You will work closely with the...
-
Regulatory Compliance Expert
15 hours ago
Copenhagen, Copenhagen, Denmark AJ Vaccines Full timeJob SummaryWe are seeking a Regulatory Compliance Expert to join our Pharmacovigilance and Safety Team at AJ Vaccines. In this role, you will be responsible for ensuring that our operations are compliant with international regulations and guidelines.Key ResponsibilitiesEvaluate and manage global pharmacovigilance reportsDevelop and maintain SOPs and...
-
Director, Global Regulatory Affairs Project Lead
20 hours ago
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...
-
Regulatory Affairs Specialist
1 day ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs at Black Swans Exist is responsible for ensuring that the company's products meet global regulatory requirements, focusing on the USA and Europe. This role develops and executes regulatory compliance strategies, navigates approval processes for pharmaceuticals and medical devices, and ensures timely updates for existing...