CMC Regulatory Strategy Manager

We are looking for a highly skilled CMC Strategy Manager to join our Regulatory Affairs CMC team at Genmab A/S. As a key member of our team, you will be responsible for developing and executing sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.The ideal candidate will have a...

Company OverviewGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. With a core purpose guiding its team, Genmab has invented next-generation antibody technology platforms and leveraged translational research and data sciences.Job DescriptionWe are seeking a highly...

Job Overview As (Senior) CMC Technical Integration Manager, you will be developing and supporting the required analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio. You will integrate these strategies into projects where the CMC development path is deviating from the Genmab CMC platform and where specific...

About the OpportunityWe are seeking a highly motivated CMC Technical Integration Manager to join our team in New Product Introduction (NPI) CMC. As a key member of the CMC Integration Team, you will be responsible for developing and supporting analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.Your primary focus...

Company OverviewGenmab A/S is an international biotechnology company committed to building extraordinary futures together. We develop antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our mission is to transform the lives of people with cancer and other serious diseases with...

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...

Oresund Pharma ApS is a dynamic and ambitious company seeking a talented Global Regulatory Manager to join our Regulatory department.In this role, you will be responsible for ensuring that our products comply with regulatory requirements and commercial demands worldwide. This includes managing regulatory submissions, establishing relationships with...

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 (Senior) CMC Technical Integration Manager Locations: Copenhagen Time Type: Full time Posted on: Posted 2 Days Ago Job Requisition ID: R11639 At Genmab, we're committed to building extraordinary...

Job SummaryWe're looking for a highly skilled Biopharmaceutical CMC Leadership Role professional to join our Regulatory Affairs CMC team. As a Team Lead, you will be responsible for leading a sub-team while actively contributing to regulatory projects. Your experience in developing and executing CMC strategies, collaborating with cross-functional teams, and...

At Genmab, we're committed to building extraordinary 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 science,...

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 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 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...

We are looking for a skilled Regulatory Affairs Manager to lead our product regulatory compliance efforts at Oresund Pharma ApS.This is a mid-senior level role that requires a deep understanding of regulatory requirements and processes. The ideal candidate will have a proven track record of managing complex regulatory projects, ensuring timely and...

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

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...

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...

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...

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...