Global Regulatory Affairs Leader

Job DescriptionWe are looking for a skilled Director/Associate Director to join our Regulatory Affairs CMC team in Copenhagen, Denmark.You will be responsible for operational and strategic regulatory CMC input to support worldwide development and commercialization of biological products. Your main duties will include developing and executing sound global...

We are looking for an exceptional Global Regulatory Affairs Manager to join our team. This individual will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects, representing RA in the Clinical Trial Teams, and ensuring progress of multiple clinical trial submission activities.The Role & DepartmentThis position...

Genmab A/S is looking for a highly motivated and experienced Regulatory Manager to join our Global Affairs team. In this role, you will be responsible for supporting the Global Regulatory Lead and/or Regional Regulatory Lead in the preparation of regulatory documentation and submissions to health authorities.You will work closely with cross-functional teams...

Genmab A/S is dedicated to creating life-changing antibody therapeutics for patients with cancer and other serious diseases. As a Regulatora Affairs Strategist in our Global Regulatory Affairs organization, you will play a key role in shaping the regulatory strategy for our products.Your primary responsibility will be to support the Global Regulatory Lead...

Innovative solutions for a better tomorrowRadiometer Danmark / Danaher is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We strive to make a difference in people's lives by providing cutting-edge technology and solutions.The Senior Manager, RA Processes, Systems and Tools plays a crucial role in driving process...

About the RoleAs an Associate Director, Global Regulatory Affairs Project Lead at Genmab, you will play a key role in our Global Regulatory Affairs organization. Your primary responsibility will be to represent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of multiple, often highly complex, clinical trial submission...

About the Role\As a Senior Counsel, Regulatory Affairs, you will be part of Mastercard's Global Regulatory Team, responsible for facilitating the strategic development of our open banking business in Europe. This role is based in Denmark and will support Mastercard Open Banking Services EU (MCOBS EU) subsidiary that holds PIS and AIS regulatory license in...

We're dedicated to creating life-changing treatments at Genmab, and we're seeking a highly skilled Biopharmaceuticals Regulatory Affairs Specialist to join our Regulatory Affairs CMC team.Director/Associate Director, Global Regulatory Affairs - CMCIn this critical role, you will be responsible for providing regulatory CMC input to support worldwide...

Get AI-powered advice on this job and more exclusive features.Senior Business Development Consultant at Black Swans ExistDirector of Regulatory AffairsAre 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, seeks a...

About the RoleWe are looking for a Senior Director to join our Global Regulatory Affairs organization in the EU/ROW region. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.The successful candidate will have...

Company OverviewRadiometer Danmark / Danaher is a leading company in the diagnostics industry, working towards improving global healthcare with reliable, fast, and easy patient diagnoses. We are proud to work alongside a community of six fellow Diagnostics Companies at Danaher.Job DescriptionThe Senior Manager, RA Processes, Systems and Tools for Radiometer...

Job DescriptionWe are seeking a highly skilled and experienced Strategic Director of Regulatory Affairs to join our team at Genmab. In this role, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.You will provide strategic input and...

About the PositionWe are seeking a highly skilled Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the opportunity to utilize your expertise to drive regulatory compliance and quality in clinical trials.ResponsibilitiesDrive regulatory compliance and quality in...

We are seeking a Regulatory Affairs Specialist to join our Life Cycle Management (LCM) Product team at Sandoz Nordic.This role involves responsible for all life cycle management activities for your defined portfolio, ensuring regulatory compliance and collaborating with Supply Chain/Planning/QA/QC and Global RA teams.The ideal candidate will have a strong...

At Genmab, we're driven to push the boundaries of innovation in developing groundbreaking cancer treatments and therapies.Director/Associate Director, Global Regulatory Affairs - CMCWe're seeking a seasoned Regulatory Affairs Director Lead to join our team and play a pivotal role in shaping the future of biologics development. As a key member of our CMC...

Join Our TeamWe are seeking an experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. The successful candidate will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of clinical trial...

About the JobHurecon, a leading pharmaceutical company, is seeking an experienced Regulatory Affairs professional to join our team in Copenhagen. As a key member of our regulatory department, you will be responsible for maintaining and following up on global Marketing Authorizations on the European Market.Key Responsibilities:Maintain and follow up on global...

The role of a Regulatory Affairs Specialist at Hurecon involves managing the entire lifecycle of European Union (EU) procedures from application submission to national implementation. This position requires a strong understanding of regulatory legislation and guidelines in the pharmaceutical industry.Responsibilities:Maintain and follow up on global...

Oresund Pharma ApS is a Nordic based privately owned specialty pharmaceutical company focusing on marketing value-added products in the European countries. We work with a large network of contract manufacturers, suppliers, wholesalers, and distributors, which provide us with a very dynamic, flexible, and scalable business structure.Our team consists of 4...

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...