Regulatory Systems Manager

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...

København S, DK, 2300 Job ID: 23315 Are you passionate about navigating regulatory changes and staying ahead of the regulatory trends? We are seeking a dynamic Regulatory Manager to join our team and support our organization in analyzing the impact of upcoming EU and local Nordic regulatory changes. At Nordea, we're committed to being a partner our...

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...

Genmab is a pioneering biotechnology company transforming the lives of patients through innovative cancer treatment and antibody therapeutics. We're seeking a Senior Regulatory IT System Specialist to join our team in maintaining, developing, and operating our enterprise electronic document management system (EDMS), GenDocs.As a key member of our Digital...

Radiometer Danmark/Danaher is a leading company in diagnostic innovation, aiming to enhance global healthcare through technology and solutions. Our team consists of over 4000 employees worldwide who share a common purpose: improving patient care.We are currently seeking a highly skilled professional to join our Global Regulatory Affairs team as Senior...

Key ResponsibilitiesThe Quality Compliance Officer will be responsible for:Ensuring compliance with regulatory requirements.Performing delegated duties concerning regional Wholesale Distribution licences.Maintaining Norgine's Nordics quality management systems.Supporting successful regulatory inspections.Generating regional metrics.Contributing to risk...

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...

Radiometer Danmark/Danaher is dedicated to advancing diagnostic innovation and enhancing global healthcare through technology and solutions. Our goal is to make a meaningful impact by improving patient care.We are seeking a highly motivated individual to join our Global Regulatory Affairs team as Senior Manager, RA Processes, Systems and Tools.As part of...

About RadiometerRadiometer is a leading manufacturer of in vitro diagnostic instruments and consumables, dedicated to improving global healthcare through reliable, fast, and easy patient diagnoses. Our vision is to improve patient lives by making accurate diagnoses possible.As a key member of our team, you will be responsible for driving process improvements...

At Genmab, we're dedicated to transforming the lives of patients through innovative cancer treatment and antibody therapeutics. As a leading international biotech company, we're committed to innovation, excellence, and collaboration.We're currently seeking a System Manager to join our team in Copenhagen, Denmark, where you will play a key role 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...

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,...

As a Senior Regulatory Publisher & Submission Manager at Macure Pharma, you will play a key role in shaping regulatory processes and implementing our new Submission Publishing Tool.Your responsibilities will include:Compiling, formatting, and validating regulatory submissions in eCTD.Implementing and optimizing our digital document management system to...

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...

About Radiobotics ApSWe are a dynamic and innovative company dedicated to solving the global need for radiologists while ensuring every patient receives expert-level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and first-line reported by our products.We are seeking a Quality Management System Lead to join our team....

In this role, you will have the opportunity to work on a wide range of projects, from developing and implementing quality management systems to collaborating with cross-functional teams to deliver high-quality products. As a QA/RA specialist, you will be responsible for ensuring compliance with regulatory requirements, including MDR and ISO 13485.Our TeamYou...

About the RoleGenmab is seeking a skilled System Manager to lead the optimization and innovation of our enterprise electronic document management system (EDMS), GenDocs, based on the Veeva Vault cloud platform. This individual will be responsible for maintaining, developing, and operating the system, covering clinical development, regulatory affairs, CMC,...

Radiobotics ApS is a pioneering company that aims to solve the global need for radiologists while ensuring every patient receives expert-level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and 1st line reported by our products, enabling non-specialists to safely and effectively handle imaging outside the hospital.We...

About the Role:Abacus Medicine A/S is seeking an exceptional Deputy Manager to lead one of our three teams in the Regulatory Marketing Authorization department. As a key member of our team, you will be responsible for managing new application and maintenance processes for parallel trading. This involves leading a team of approximately twenty colleagues to...

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...