Regulatory Affairs Expert, Biological Products

At Genmab A/S, we are committed to pushing the boundaries of innovative cancer treatment and serious diseases. Our mission is to develop antibody products that change the lives of patients.The Regulatory Affairs CMC team at Genmab is a highly trusted partner to our CMC organization. We are seeking a Director/Associate Director to join our dynamic, global...

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...

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...

Radiometer Danmark, part of Danaher, is dedicated to improving global healthcare with reliable, fast, and easy patient diagnoses.This challenging role as Senior Manager, Regulatory Affairs Processes, Systems and Tools offers the opportunity to drive process improvements and implement systems and tools within Regulatory Affairs to support efficient regulatory...

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...

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...

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...

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...

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...

At AGC Inc, we are seeking a highly skilled Biologics Quality Assurance Specialist to join our team. As a key member of our Quality organization, you will provide technical expertise and project leadership for the development and implementation of quality assurance strategies.Key Responsibilities:Provide cross-functional quality leadership and support...

Job Title: Regulatory Submission ManagerWe are seeking a highly motivated and experienced Regulatory Submission Manager to join Genmab.About the RoleProvide submission managing for MAA, BLA, and IND applicationCollaborate with project managers, regulatory leaders, and content authors to discuss planned submission preparationRepresent Regulatory Operations on...

As a Senior Manager, Drug Product Strategy, you will play a critical role in driving the development of innovative biologic drug products. This is a unique opportunity to join a leader in biologics development and contribute to groundbreaking therapies that transform lives.About Barrington James:Barrington James is a leader in biologics development,...

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...

IT Application Solutions ExpertCopenhagen, Denmark - Full time jobAbout the RoleAn IT Application Solutions Expert is needed to manage changes to existing configured screens or fields.Main Responsibilities:Manage project configurations according to customer requirements.Collect and analyze customer needs, then recommend product updates.Create and maintain...

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...

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...

At Radiobotics, we are seeking an experienced QA/RA specialist to join our Clinical and Regulatory team. This is a temporary consultancy position to support the company while we search for a permanent hire.The ideal candidate will have at least 1 year of experience in quality assurance and/or regulatory affairs within the medical device field. They will be...

Company OverviewWe are a next-generation fintech company that aims to empower entrepreneurs and small businesses with financial superpowers. Our mission is to back the brave founders who dare to challenge the status quo and create a more just and equitable financial system.Salary and BenefitsWe offer a competitive compensation package that includes a sizable...