Regulatory Affairs Director Lead

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 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 RoleGenmab is seeking an experienced Senior Manager/Associate Director to lead our Global Regulatory Affairs organization as EU/ROW Regulatory Lead. In this role, you will represent RA in Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.Key...

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...

About YouWe are looking for a highly experienced 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...

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 Black Swans ExistBlack Swans Exist is a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health. We are shaping the future of women's health by developing innovative biologics and combination drug-device products.The RoleWe seek a visionary Director of Regulatory Affairs to lead our global regulatory...

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...

About the RoleWe are seeking an experienced and skilled individual to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. You will act as the representative of RA on Clinical Trial Teams...

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...

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...

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 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...

About the RoleWe are seeking a highly skilled Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab. This individual will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.The successful candidate will work closely with...

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...

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...

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...

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...

At Ascendis Pharma, we are committed to making a meaningful difference in patients' lives. We are seeking a highly experienced Regulatory Affairs and Policy Lead to join our team and drive the development of our governmental affairs strategy.This role will involve working closely with internal stakeholders to ensure alignment with our core values and...

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...