Head of Global Regulatory Affairs and R&D Quality

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...

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...

About UsTopsoe is a leading global provider of technology and solutions for the energy transition. We combat climate change by helping our customers and partners achieve their decarbonization and emission reduction goals.Our team consists of over 2,800 employees serving customers all around the globe. To learn more, visit our website.The RoleWe are seeking a...

About the RoleWe are seeking an experienced leader to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs Strategy-EU/RoW. This role will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products.The ideal candidate will have a strong...

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 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 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...

About the RoleGenmab A/S is seeking an experienced and passionate leader to join our Global Regulatory Affairs organization. In this role, you will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products. You will provide strategic input and ensure operational execution of...

Medical Documentation Leadership RoleThis is an exciting opportunity to lead the Medical Documentation department at Lundbeck A/S, H. As the Head of Global Regulatory Affairs and R&D Quality, you will be responsible for driving digital transformation and enhancing R&D productivity through change management initiatives, implementation of innovative digital...

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 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...

Senior Director, Head of Medical DocumentationRequisition ID: 5988Location: Copenhagen, Danish Capital Region, DKSenior Director, Head of Medical DocumentationJoin Lundbeck as the Head of Medical Documentation and play a pivotal role in shaping our commitment to advancing brain health. This position offers a unique opportunity to create a lasting impact...

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...

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...

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...

We are seeking a highly motivated and experienced Regulatory Affairs Professional to join our life cycle management team at Sandoz Nordic.Company OverviewSandoz, a leading global generics and biosimilars company, is committed to providing high-quality medicines to patients around the world. With a strong presence in over 100 countries, we strive to make a...

About the Role:This is a temporary consultancy position to support our permanent hire search.We seek an experienced QA/RA specialist with a strong background in product registrations and quality management systems. The ideal candidate will have a flair for product quality, be curious about new markets, and passionate about medical device software.The...