Director of Regulatory Strategy and Development

About the PositionWe are seeking an experienced Associate Director to join our Global Regulatory Affairs organization as EU/ROW Regulatory Lead. In this role, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects.Your Key AccountabilitiesDevelop and implement EU/ROW regulatory strategies to ensure compliance...

Transforming Healthcare Through Regulatory ExcellenceRadiometer Danmark / Danaher is at the forefront of developing diagnostic solutions that improve health outcomes worldwide. Our commitment to regulatory excellence enables us to bring life-changing technologies to market efficiently and safely.The Senior Manager, RA Processes, Systems and Tools is a...

About the RoleAs a Senior Director, Regulatory Affairs Strategy-EU/RoW, you will join our Global Regulatory Affairs organization and assume responsibility for EU/ROW regulatory strategy for assigned program. You will manage a group of Regulatory Strategists with EU/ROW responsibilities for Genmab's programs across all stages of development.The successful...

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...

Genmab A/S is a biotechnology company that aims to transform the lives of people with cancer and other serious diseases through innovative and differentiated antibody therapeutics. Our team has developed a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and...

About the RoleThe Regulatory Affairs CMC team at Genmab is seeking a highly experienced Director/Associate Director to support worldwide development and commercialization of biological products.As a key member of the team, you will be responsible for developing and executing sound global regulatory CMC strategies for early and late-stage development, as well...

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...

The Director of Regulatory Affairs at Black Swans Exist plays a pivotal role in ensuring the company's products meet global regulatory requirements. This position focuses on compliance with regulations set by authorities such as the FDA and EMA, ensuring timely updates for existing products. The ideal candidate will have deep expertise in drug regulations...

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...

Job SummaryWe 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...

At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products that change the lives of patients and the future of cancer treatment.The Regulatory Affairs CMC team is evolving and we are therefore looking for a Director/Associate Director to join our dynamic team. The successful candidate will be responsible...

About UsAt Black Swans Exist, we're passionate about revolutionizing microbiome-based therapies for women's reproductive health. Our mission is to develop innovative biologics and combination drug-device products that transform lives.The JobWe're seeking a highly experienced Director of Regulatory Affairs to lead our global regulatory strategies. As a key...

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...

About the OpportunityWe are excited to announce an opportunity for a seasoned Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the chance to leverage your expertise to drive regulatory compliance and quality in clinical trials.Key ResponsibilitiesLeverage your...

ResponsibilitiesThe Senior Director will be responsible for the following:* Developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products* Managing multiple projects simultaneously, including clinical trial applications, marketing authorizations, and variations* Leading teams...

Our CultureGenmab fosters a culture of collaboration, mutual respect, and open communication. Our team is composed of talented individuals who share a passion for innovation and excellence. We strive to create an environment where every employee feels valued, supported, and empowered to contribute to our shared success.About the PositionWe're seeking a...

About the JobThis is an exciting opportunity to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. As a key member of our team, you will play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of clinical trial submission...

We are seeking a highly experienced Director of Regulatory Planning and Operations to join our Global Regulatory Affairs organization. In this critical role, you will develop and execute the EU/ROW regulatory strategy, collaborate closely with the Global Regulatory Team on one or multiple compounds in early or late-stage development, and serve as the primary...

At Genmab, we are committed to developing innovative and differentiated antibody therapeutics that transform the lives of patients with cancer and other serious diseases.About the RoleThe Senior Manager/Associate Director, EU/ROW Regulatory Lead will play a critical role in our Global Regulatory Affairs organization. This individual will represent RA in...

Company OverviewBlack Swans Exist is a pioneering biotech company dedicated to revolutionizing microbiome-based therapies for women's reproductive health. Our vision is to develop innovative biologics and combination drug-device products that improve women's lives.The PositionWe're seeking an experienced Director of Regulatory Affairs to lead our global...