Regulatory Affairs Director

About 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...

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 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...

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...

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...

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...

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...

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...

Regulatory 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,...

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...

Our 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...

We are seeking a dedicated and experienced professional to join our Regulatory department as a Regulatory Affairs Manager. This role will be responsible for ensuring the compliance of Oresund Pharma's products with regulatory requirements worldwide.Key Responsibilities:Develop and maintain a product portfolio following regulatory requirements and commercial...

Company 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...