Regulatory Affairs Specialist

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...

At Genmab, we're committed to creating extraordinary futures together by developing innovative antibody products and therapies that change the lives of patients. As our Senior Manager EU/ROW Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy and ensuring compliance with EU and ROW regulations.As a key member of our Global...

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...

About the JobGenmab A/S is seeking an experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs team. The successful candidate will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization...

Job DescriptionThe Regulatory Affairs team at Genmab A/S is seeking an experienced professional to fill the role of Director/Associate Director, Global Regulatory Affairs. The successful candidate will be responsible for providing strategic regulatory guidance on CMC topics, collaborating with cross-functional peers, and planning and preparing CMC...

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...

About the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist for Site Activation in the Nordics region.You will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to local and international regulations, standard operating procedures (SOPs), project...

Welcome to Euro Federation of Organizations for Medical Physics - EFOMP, where we strive to bring innovative medical solutions to the market while prioritizing patient safety and well-being. As a Regulatory Affairs Manager, you will be a crucial member of our team, responsible for ensuring our products comply with relevant regulations and standards.You will...

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...

At Radiometer Danmark, we're committed to improving global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our Global Regulatory Affairs team, you'll play a crucial role in driving process improvements and implementing systems and tools to support efficient regulatory support for the organization and growth of the company.Job...

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...

As our Senior Manager EU/ROW Regulatory Affairs, you'll be responsible for ensuring that our regulatory affairs functions are operating effectively and efficiently. This includes representing RA in clinical trial teams, ensuring regulatory oversight and progress of multiple clinical trial submission activities, and representing EU/ROW in the Global...

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...

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...

At Genmab, we are committed to pushing the boundaries of cancer treatment through innovative therapies. As a key member of our Global Regulatory Affairs organization, you will play a vital role in developing and executing EU/ROW regulatory strategies for our compounds.">The Role & DepartmentYou will join our dynamic team as an (Associate) Director, Global...

Job RoleThe Director/Associate Director, Global Regulatory Affairs will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.This role requires strong leadership and...

CareerArc is seeking a seasoned Regulatory Affairs Expert to lead the development of our open banking business in Europe. As a key member of the Global Regulatory Team, you will play a critical role in shaping our strategy and ensuring regulatory compliance across multiple jurisdictions.About the RoleIn this role, you will advise on supervision and...

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...

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...

We are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We strive to learn what happens beyond the surface and show up every day ready to engage and have fun with each other. Our vision is to solve the global need for radiologists while ensuring every patient receives expert-level care.As a Quality Management System Professional, you...