Manager of Regulatory Affairs

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...

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...

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...

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...

About the RoleAt Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and...

Black Swans Exist, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a seasoned Director of Regulatory Affairs to spearhead their global regulatory strategies.About the RoleIn this high-impact position, you will drive the development and approval of innovative biologics, combination drug-device...

Get AI-powered advice on this job and more exclusive features. Senior Business Development Consultant at Black Swans Exist Director of Regulatory Affairs Are you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health,...

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...

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...

**Job Summary**GROHE AG seeks a Regulatory Affairs Manager to lead the development and implementation of trade compliance strategies across the organization. The ideal candidate will have a strong background in trade regulations and laws, as well as excellent leadership and communication skills.**Key Responsibilities**Develop and maintain comprehensive...

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...

We are looking for an exceptional individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring regulatory compliance and oversight for our clinical trials.In this role, you will represent RA in Clinical Trial Teams and...

About the Role:The Associate Director Regulatory Strategy will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. This role will represent EU/ROW in the Global Regulatory Team(s) and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Develop...

Transform Lives through Innovative Cancer TreatmentWe are 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...

Job Summary:We are seeking a highly skilled Quality and Regulatory Affairs Consultant to join our Clinical and Regulatory team. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest quality standards and...

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...

At Macure Pharma, we are seeking a seasoned Regulatory Affairs Specialist to join our team. This role offers an exciting opportunity to shape regulatory processes in a fast-growing company and play a key role in the implementation of our new Submission Publishing Tool.Key Responsibilities:Compiling, formatting and validating regulatory submissions in eCTD...

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...

Job Description:We are looking for a Regulatory Affairs Expert for Medical Devices to join our Clinical and Regulatory team. The ideal candidate will have a strong background in regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest regulatory standards and that we comply with...

This is an excellent opportunity for someone who is passionate about quality and regulatory affairs to join a leading company in the medical device industry. As a QA/RA specialist, you will be responsible for ensuring compliance with regulatory requirements, including MDR and ISO 13485, and will have the opportunity to work on a wide range of projects, from...