Regulatory Affairs Director

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...

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,...

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 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...

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...

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 Workday@Genmab.com.Director/Associate Director, Global Regulatory Affairs - CMCAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering...

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. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly unique,...

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...

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...

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 Overview:The Senior Director of Global Regulatory Affairs will lead Tbwa Chiat/Day Inc's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business objectives. This role involves overseeing the company's engagement with regulatory bodies, shaping public policy initiatives, and ensuring seamless...

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...

Job OverviewWe are seeking an experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs team at Genmab A/S. 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...

Regulatory Affairs Expertise for a Leading Biotech CompanyWe are seeking a highly experienced and skilled Director of Regulatory Strategy and Operations to join our team at Genmab A/S. As a key member of the Global Regulatory Affairs organization, you will play a critical role in shaping the company's regulatory strategies and ensuring the successful...

At Genmab, we're committed to transforming the lives of patients through innovative cancer treatments. Our Global Regulatory Affairs organization is seeking a highly motivated and experienced individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead.This role will involve representing RA in Clinical Trial Teams and working...

At Genmab, we strive to build an unstoppable team that improves the lives of patients through innovative cancer treatment.We need an experienced Senior Director to lead our Global Regulatory Affairs organization. The successful candidate will develop global strategies to advance our portfolio of development pipeline candidate drugs and marketed products.In...

The Regulatory Director will serve as a key regional leader for the company's regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing the unique requirements of local markets. Acting as a bridge between the VP of Public Policy & Regulatory Affairs, other Regional Regulatory Directors, and local teams, this...

General Role Overview: The Global VP/Head of Public Policy and Regulatory Affairs will lead AstroPay's global regulatory strategy, ensuring compliance, alignment and influence in a rapidly evolving fintech environment with a strong international focus. This executive role will oversee the company's engagement with regulatory bodies, shape public policy...

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...