Regulatory Submission Expert

OverviewGenmab is a leading biotechnology company committed to delivering innovative antibody therapeutics to patients worldwide. Our team of experts is driven by a shared passion for advancing cancer treatment and improving patient outcomes.The JobWe are seeking a highly experienced Regulatory Submission Manager to join our team. As a key member of our...

Job SummaryGenmab is seeking a highly skilled Regulatory Submission Manager to join our team. As a key member of our regulatory operations group, you will be responsible for managing all submissions, including MAA/BLA/IND applications, ensuring compliance and adherence to timelines.Your Key ResponsibilitiesDevelop and implement submission strategies to...

About the RoleWe are seeking an experienced Regulatory Affairs Professional to join our team as a Global Regulatory Lead. This challenging position will involve driving the development of innovative therapies for diseases within Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas.Ferring Pharmaceuticals A/S is dedicated to advancing...

Regulatory Submission Manager PositionWe seek an experienced Regulatory Submission Manager to manage submissions for MAA, BLA, and IND applications, collaborate with cross-functional teams, and drive timely delivery of submission documents.Key ResponsibilitiesOversee submission management to ensure compliance and accuracyDevelop and maintain relationships...

About UsGenmab is an innovative biotechnology company dedicated to improving the lives of patients through pioneering antibody therapies. Our mission is to transform the cancer treatment landscape with cutting-edge, data-driven solutions.The RoleWe are seeking a highly skilled Regulatory Affairs professional to join our team as a Global Regulatory Submission...

At Genmab, we're dedicated to pushing the boundaries of cancer treatment and serious diseases. Our team of experts is committed to developing innovative antibody products that transform patients' lives.The Role & DepartmentWe're seeking an experienced Global Regulatory Affairs Project Lead to join our Global Regulatory Affairs organization. As a key member...

About RadioboticsRadiobotics is a dynamic company on a mission to revolutionize the field of radiology. Our vision is to make expert-level care accessible to every patient, and we're committed to achieving this goal through innovative solutions.Job SummaryWe're seeking an experienced QA/RA specialist to join our Clinical and Regulatory team. As a key member...

About Roche Pharmaceuticals A/SWe are a research-focused healthcare group built on innovation, curiosity, and diversity.Our MissionWe strive for excellence in everything we do by embracing individuality and sharing a passion for exceptional care.The PositionWe seek a dedicated and motivated Drug Regulatory Affairs Partner with a structured and...

About the Role"Genmab is an international biotechnology company driven by its core purpose: to improve the lives of patients through innovative and differentiated antibody therapeutics. Our passionate team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to result in a proprietary pipeline...

As a Regulatory Affairs Director EU/ROW Lead at Genmab A/S, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects.About the RoleThis is a key member position within the Global Regulatory Affairs organization at Genmab A/S.Key Accountabilities:Act as EU/ROW Regulatory Lead for assigned projects.Develop and...

Genmab is committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We are seeking a talented Senior Director to lead our Global Regulatory Affairs organization and drive our strategic initiatives forward.Job...

At Genmab, we are dedicated to pioneering therapies that transform the lives of patients and redefine cancer treatment. Our team is driven by a shared passion for innovation, excellence, and customer-centricity.About the RoleWe are seeking an experienced Senior Director to lead our Global Regulatory Affairs organization. As a key member of our leadership...

At Genmab A/S, we're committed to delivering innovative antibody therapeutics that change the lives of patients and transform the future of cancer treatment.The Regulatory Affairs CMC team is responsible for ensuring the global regulatory compliance of our biological products throughout their development and commercialization lifecycle. We are seeking a...

We are looking for a highly skilled Regulatory Strategy and Operations Manager to join our team at Genmab. As a key member of our Regulatory Affairs organization, you will play a critical role in developing and executing global strategies to advance our portfolio of development pipeline candidate drugs and marketed products.Key ResponsibilitiesDevelop and...

Join Our TeamWe are seeking a highly skilled Biotech Expert to join our Late Stage Manufacturing Development (LSMD) Team as a CMC Analytical Specialist. In this role, you will be responsible for developing and implementing analytical strategies for ongoing projects and ensuring compliance with industry standards and regulatory guidance.Key...

Sustainable change starts with responsible leadership. At Ramboll, our core strength is our people, and our history is rooted in a clear vision of how a responsible company should act.Job ResponsibilitiesWe are looking for a Senior Global Speak Up Manager to join our Group Business Integrity, Cyber and Information Security & Compliance Department. The ideal...

About GenmabGenmab is an innovative biotechnology company dedicated to transforming the lives of patients through groundbreaking antibody therapies. With a strong focus on translational research and data sciences, we've established a robust pipeline of next-generation antibody technologies.The RoleWe're seeking a seasoned Senior Director, Regulatory Affairs...

Role OverviewFerring Pharmaceuticals A/S seeks a seasoned Global Regulatory Affairs Manager to lead the lifecycle projects for one of our products in the Small Molecule team.ResponsibilitiesDevelop and execute regulatory strategies for worldwide market expansions and approvals, ensuring compliance with global regulatory requirements.Collaborate with...

Job Title: Senior Document CoordinatorGenmab seeks an experienced Senior Document Coordinator to manage submissions, collaborate with cross-functional teams, and drive timely delivery of submission documents.About the RoleManage submission process to ensure compliance and accuracyDevelop and maintain relationships with project managers, regulatory leaders,...

Regulatory Compliance Specialist - Financial CrimeSaxo Group is seeking a highly experienced Regulatory Compliance Specialist to lead our efforts in preventing financial crime and ensuring regulatory compliance worldwide.The successful candidate will have expertise in reviewing and maintaining clear policies and procedures for digital onboarding and ongoing...