Director of Regulatory Affairs and Project Leadership
2 days ago
We 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 the clinical trial submissions in EU/ROW.
You will be responsible for representing EU/ROW in the Global Regulatory Team(s), acting as EU/ROW regulatory lead for assigned projects, and leading the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc. Additionally, you will plan, prepare, and lead EMA or national Scientific Advice procedures as relevant, evaluate regulatory risks, and recommend mitigation strategies to cross-functional teams and management.
Key Responsibilities- Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
- Represent EU/ROW in the Global Regulatory Team(s).
- Act as EU/ROW regulatory lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW strategy.
- Lead the preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, etc.
- Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
- Evaluate regulatory risks and recommend mitigation strategies to the cross-functional teams and management.
-
Regulatory Affairs Project Director
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob 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...
-
Regulatory Affairs Director
13 hours ago
Copenhagen, Copenhagen, Denmark Pandora AS Full timeAbout the JobPandora A/S is seeking a highly motivated and experienced Regulatory Affairs Director to lead our global regulatory affairs function. As a key member of our team, you will be responsible for ensuring that we maintain the highest standards of regulatory compliance and integrity.Main ResponsibilitiesDevelop and implement effective regulatory...
-
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...
-
Regulatory Affairs Associate Director
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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...
-
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...
-
Global Regulatory Affairs Project Lead
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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...
-
Global Regulatory Affairs Leader
2 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout 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...
-
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 Manager
18 hours ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeJob 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...
-
Regulatory Affairs Director
2 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob 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...
-
Global Regulatory Affairs Project Lead
13 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking an experienced Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. In this role, you will be responsible for leading the development and execution of the EU/ROW regulatory strategy for assigned projects.Key ResponsibilitiesAct as EU/ROW regulatory lead and EMA contact person for assigned...
-
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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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...
-
Regulatory Affairs Director
13 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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...
-
Regulatory Affairs Lead
15 hours ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeJob 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...
-
Senior Counsel, Regulatory Affairs
3 days ago
Copenhagen, Copenhagen, Denmark CareerArc Full timeOur Purpose Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart, and accessible. Our technology and innovation, partnerships...
-
Senior Regulatory Affairs Counsel
3 days ago
Copenhagen, Copenhagen, Denmark CareerArc Full timeCompany OverviewCareerArc powers economies and empowers people in 200+ countries and territories worldwide. We're helping build a sustainable economy where everyone can prosper. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses, and governments realize their greatest...
-
Senior Director, EU/ROW Regulatory Affairs
2 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout 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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab 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...
-
Pharmaceutical Regulatory Affairs Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeRegulatory Affairs Document SpecialistWe are seeking a highly skilled Regulatory Affairs Document Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6,...