Biotechnology Regulatory Affairs Expert

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...

We are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We believe in integrity, transparency, and open communication. Our vision is to augment routine X-rays of the musculoskeletal system, enabling non-specialists to read radiology images assisted by our products, and ensuring patients have access to immediate expert-level evaluation...

About the JobGenmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.We are seeking a talented individual to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs...

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...

Job Overview:This is a mid-senior level full-time position requiring a strong understanding of CMC development and regulatory affairs.Coordinate inputs across departments and external stakeholdersManage risk proactively using scientific and operational insightPrepare and facilitate technical project meetingsKey Skills:Project management experience in biotech...

Innovative Antibody Therapies: Collaboration OpportunityJob DescriptionWe're seeking a seasoned expert in regulatory stability to join our CMC Stability team in Denmark. As a key contributor to our Clinical Pipeline, you will play a vital role in managing stability activities and collaborating with internal and external stakeholders.Your responsibilities...

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...

In this exciting role as Medical Device Regulatory Affairs Expert, you will be responsible for ensuring that our products comply with relevant regulatory requirements. You will work closely with cross-functional teams to drive product releases and ensure that our products meet the highest standards of quality and safety.A key aspect of this role is staying...

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...

Nordea's commitment to regulatory excellence is reflected in its dedication to fostering a collaborative environment where employees can thrive. As a Regulatory Manager, you will be part of a dynamic team focused on staying ahead of regulatory trends and ensuring seamless compliance.In this critical role, you will be responsible for:Identifying and...

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...

Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics. Our team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to create a proprietary pipeline including bispecific T-cell engagers,...

Job Description">We are looking for a detail-oriented Regulatory Affairs Coordinator to join our team. In this role, you will be responsible for supporting trial teams in executing global and national clinical trial disclosure requirements across Genmab's entire portfolio.">Your Key Responsibilities">You will assist in managing, tracking, and overseeing...

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...

Job Title: Regulatory Affairs CoordinatorIQVIA Argentina is seeking a highly skilled Regulatory Affairs Coordinator to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, providing training and support to sites, and collaborating with the study team to track the progress of assigned studies.Key...

As a Compliance Manager - Regulatory Affairs, you will be responsible for handling change controls and deviations in GxP validated IT Systems. You will also act as an expert, ensuring compliance with regulatory guidelines and providing guidance on national and EU legislation within the regulatory field.About UsSandoz, a leader in generic and biosimilar...

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...

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 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...

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...