Regulatory Affairs Project Lead Position

About GenmabAt Genmab, we're a biotechnology company with a mission to transform the lives of patients through innovative cancer treatment and therapies. We're driven by our core purpose to strive towards improving patient outcomes with next-generation antibody technology platforms and translational research. Our team is passionate about developing...

Job 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...

Job OverviewGenmab A/S is seeking a highly motivated and experienced Regulatory Affairs professional to join our Global Regulatory Affairs team as an Associate Director, EU/ROW Regulatory Lead. The successful candidate will be responsible for representing RA in the Clinical Trial Teams, ensuring regulatory oversight and progress of multiple clinical trial...

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...

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...

Sandoz International GmbH is a leading generic and biosimilar medicines company, committed to improving access to high-quality, low-cost medicines for patients worldwide. We are seeking a highly motivated Global Regulatory Affairs Manager to join our LCM Product team.In this role, you will be responsible for managing global regulatory affairs, including...

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...

About This OpportunityWe're looking for an experienced Senior Regulatory Affairs Professional to join our team at Genmab. As a key member of our Global Regulatory Affairs organization, you'll play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects. Your expertise will be essential in ensuring regulatory...

We are seeking a highly skilled Senior Manager of Regulatory Processes and Tools to join our Global Regulatory Affairs team. In this role, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for the organization and growth of the company.This position is...

Radiobotics is a dynamic and innovative company dedicated to solving the global need for radiologists while ensuring every patient receives expert-level care. We are looking for a talented QA/RA specialist to join our Clinical and Regulatory team and contribute to our mission.The ideal candidate will have a strong background in quality assurance and...

Radiometer Danmark / Danaher is a leading provider of diagnostic solutions. Our purpose is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for...

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.We're seeking a Senior Regulatory Affairs Manager to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible...

Genmab is committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.We're seeking a Regulatory Strategy Lead to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for operational and strategic regulatory CMC input to support worldwide development...

Role 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...

The 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...

Oresund Pharma ApS is seeking a dedicated and experienced Regulatory Affairs Manager to join our team.Responsibilities:Lifecycle management of productsEnsuring compliance with regulationsPreparation and review of regulatory submissionsMaintenance of product informationMonitoring and setting timelinesKeeping up-to-date with legislation and...

We are seeking a dedicated and experienced Regulatory Affairs Manager.As part of our team, you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a global product portfolio following regulatory requirements and commercial demands.As Regulatory Affairs Manager, you will be responsible for your own portfolio...

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...

The 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...

As a Regulatory Affairs Expert at Radiometer Danmark, you will play a critical role in ensuring compliance with applicable standards and regulations within the organization. You will be responsible for handling quality management systems and supporting processes, participating in and driving smaller projects in the RA/QA function with manageable risks and...