Antibody Therapeutics Project Lead
1 month ago
Genmab is a pioneering biotechnology company committed to developing groundbreaking antibody therapies that transform the lives of patients with cancer and other serious diseases. Our team of experts is dedicated to harnessing the power of innovative technology platforms, translational research, and data sciences to create next-generation medicines.
We are seeking an exceptional Antibody Therapeutics Project Lead to join our Global Regulatory Affairs organization. In this critical role, you will assume responsibility for driving the EU/ROW regulatory strategy for assigned projects, collaborating closely with cross-functional teams to ensure optimal product development.
Key Responsibilities:
- Develop and execute EU/ROW regulatory strategies for multiple compounds in early or late-stage development
- Represent RA on Clinical Trial Teams, ensuring regulatory oversight of clinical trial submission activities
- Evaluate competitive landscapes and regulatory mechanisms to optimize product development and expedite market access in EU/ROW
- Prepare strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, and PRIME
- Plan and lead EU and national Scientific Advice procedures
- Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management
- Maintain expertise on regulatory topics, guidelines, and regulations impacting Genmab products
Requirements:
- A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field; Master's degree preferred
- Minimum 7-8 years of experience in Regulatory Affairs, preferably in development phase
- Significant experience in proactively planning and executing complex clinical submission strategies
- Solid understanding of drug development and EU regulatory mechanisms
- Prior experience leading health authority meetings with EMA or other health authorities, as well as experience with PIPs
The estimated salary for this position is around $120,000-$180,000 per year, depending on location and experience. As a valued member of our team, you can expect a comprehensive benefits package, including opportunities for professional growth and development.
This role is located in Copenhagen, Denmark, and offers a hybrid work arrangement. If you are passionate about transforming lives through innovative cancer treatment, we encourage you to apply. We strive to maintain a diverse, inclusive, and equitable workplace where everyone feels valued and empowered to contribute their best work.
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab A/S, we're seeking a highly skilled Director/Associate Director to join our Regulatory Affairs CMC team. As a key player in our global development and commercialization efforts, you will drive operational and strategic regulatory CMC initiatives.About the RoleThe ideal candidate will have a strong understanding of compliance and biologics, with a...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab A/S seeks a seasoned Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization in Copenhagen. As an integral part of the team, you will play a crucial role in ensuring regulatory oversight and progress of clinical trial submissions in the EU/ROW region.About the RoleThis is an exciting opportunity to...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to developing innovative antibody products and therapies that change the lives of patients with cancer and other serious diseases. As a key member of our facilities management team, you will play a critical role in ensuring the optimal functioning of our laboratory and office locations in Copenhagen/Ballerup.About the RoleThis is...
-
Regulatory Affairs Project Lead
10 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeCompany OverviewGenmab is an international biotechnology company with a passion for transforming the lives of patients through innovative and differentiated antibody therapeutics.With a core purpose guiding its unstoppable team, Genmab strives towards improving the lives of patients by inventing next-generation antibody technology platforms and leveraging...
-
Biopharmaceutical Project Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we are dedicated to pioneering extraordinary futures together by developing innovative antibody products and therapies that revolutionize cancer treatment and serious diseases. Our collaborative team is driven by a passion for improving patient lives through cutting-edge science.The Role and DepartmentWe are seeking a Senior CMC Project Manager to...
-
EU/ROW Regulatory Lead and Project Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob DescriptionGenmab A/S is an international biotechnology company seeking a skilled EU/ROW Regulatory Lead and Project Manager to join our Global Regulatory Affairs organization.About the RoleThis challenging position involves representing Regulatory Affairs in Clinical Trial Teams, ensuring oversight and progress of multiple clinical trial submission...
-
Biotechnology Regulatory Affairs Project Lead
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAre you passionate about developing innovative cancer treatments and improving the lives of patients?About the RoleWe are seeking an experienced Biotechnology Regulatory Affairs Project Lead to join our Global Regulatory Affairs team at Genmab, a leading international biotechnology company.As a key member of our team, you will assume responsibility for...
-
Copenhagen, Copenhagen, Denmark Liva Healthcare Full timeLiva Healthcare is a pioneering digital therapeutics company that has been preventing, managing, and treating chronic diseases through behavior and lifestyle change since 2015.As a Senior Research Manager, you will play a crucial role in shaping and delivering our clinical evidence generation strategy across obesity, prediabetes/type 2 diabetes, and...
-
Copenhagen, Copenhagen, Denmark Amgen SA Full timeAmgen SA Clinical Trial Role OverviewThis is a pivotal opportunity to drive clinical excellence in the Obesity Therapeutic Area in Denmark, with some support to the other Nordic countries. The successful candidate will emphasize scientific and medical leadership, focusing on accelerating clinical trials recruitment, ensuring subject retention, engaging with...
-
Global Regulatory Lead
2 months ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeUnlock Your Potential as a Global Regulatory Affairs ProfessionalFerring Pharmaceuticals A/S is dedicated to advancing innovative therapies for the treatment of diseases within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas. We strive to lead in innovation and adopt a global perspective, starting from the early stages of...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab A/S, we're committed to delivering exceptional biopharmaceutical products and pioneering therapies that transform the lives of patients. As a highly skilled professional in our CMC Integration Team, you will play a pivotal role in developing innovative solutions for early-stage CMC development. Our team is responsible for creating cutting-edge...
-
Digital Systems Management Lead
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeCompany OverviewGenmab is a global biotechnology company dedicated to developing innovative antibody therapeutics. Our mission is to improve the lives of patients through cutting-edge science and technology.Salary Range:$120,000 - $180,000 per yearAbout the RoleWe are seeking an experienced System Manager to join our Digital Systems Management team. As a key...
-
Chief Technical Integration Director
2 months ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we are dedicated to transforming the lives of patients through innovative cancer treatment.About the RoleWe are seeking a skilled Clinical Manufacturing and Control (CMC) Technical Integration Director to join our team in Copenhagen. As a CMC Technical Integration Director, you will play a vital role in developing and implementing...
-
CMC Integration Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Technical Operations Manager to join our CMC Integration Team in New Product Introduction (NPI) CMC at Genmab A/S. The successful candidate will be responsible for developing and supporting required analytical/process strategies for selected projects in the Genmab Early-Stage project...
-
Senior Regulatory Affairs Expert
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeUnlock your potential in a dynamic environment at Genmab, a pioneering biotechnology company dedicated to transforming the lives of patients through innovative cancer treatments and therapies. As a Senior Regulatory Affairs Expert, you will play a pivotal role in shaping our regulatory strategies and ensuring seamless clinical trial submissions.About the...
-
Antibody Product Development Manager
1 month ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are seeking a skilled and experienced Antibody Product Development Manager to join our R&D IT & Digital team, focusing on QC Lab Systems.Job Description:This is an exciting opportunity to lead the development of top-notch antibody products and innovative therapies that make a difference in the lives of patients and influence the future of cancer treatment...
-
Senior Regulatory Affairs Manager
2 months ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab is a cutting-edge international biotechnology company that strives to improve the lives of patients through innovative antibody therapeutics. With over 20 years of experience, our passionate and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to create a proprietary...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeSenior Director, Regulatory Affairs Strategy LeaderWe are seeking an experienced and passionate leader to join our Global Regulatory Affairs organization at Genmab A/S. As a Senior Director, Regulatory Affairs Strategy Leader, you will be responsible for developing global strategies to advance our portfolio of development pipeline candidate drugs and...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleWe are seeking an experienced Senior Quality Engineering Architect to drive the development and implementation of GxP solutions across our portfolio of research and clinical development platforms.Key ResponsibilitiesDesign and deliver test strategies tailored for AI/ML products, Data Engineering solutions, and SaaS offerings.Develop and enhance...
-
Facilities Operations Manager
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're dedicated to developing innovative antibody products and pioneering therapies that change lives. Our commitment to excellence drives us to create extraordinary futures for patients and cancer treatment.The Facilities Manager will oversee daily technical operations, service requests, and maintenance at our DK sites. This role offers a unique...