Regulatory Affairs Project Lead
1 month ago
We are seeking a highly skilled and experienced Regulatory Affairs Project Lead to join our Global Regulatory Strategy team at Genmab. This role will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects, ensuring compliance with regulatory requirements and guidelines.
Key Responsibilities:- Lead the development of EU/ROW regulatory strategies for assigned projects
- Closely collaborate with the Global Regulatory Team to ensure strategic alignment and effective execution
- Represent RA in Clinical Trial Teams and ensure regulatory oversight of clinical trial submission activities
- Evaluate competitive landscape and various regulatory mechanisms to optimize product development
- Prepare and lead EU and national Scientific Advice procedures as relevant
- Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field
- Minimum of 7-8 years of experience in Regulatory Affairs, preferably in development phase
- Significant experience in proactively planning and executing highly complex clinical submission strategies
- Solid understanding of drug development and EU regulatory mechanisms to expedite development
- Prior experience leading health authority meetings with the EMA or other health authorities
- You have a strong passion for improving the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do, with a firm belief in Genmab's rooted-in-science approach
- You are a collaborative and generous individual who can work effectively in teams with diverse backgrounds
The salary range for this position is $120,000 - $180,000 per annum, depending on experience and qualifications.
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're driven by a shared purpose to transform the lives of patients through innovative cancer treatment and therapies.The Role & DepartmentWe're seeking a highly skilled Regulatory Affairs Project Lead to join our Global Regulatory Team as an Associate Director. In this role, you will represent RA in the Clinical Trial Teams and work closely with...
-
Global Regulatory Affairs Project Lead
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to developing innovative antibody therapies that change the lives of patients and the future of cancer treatment. As a Global Regulatory Affairs Project Lead, you will play a key role in shaping our regulatory strategy for EU/ROW.About the Role:You will represent RA in Clinical Trial Teams and ensure regulatory oversight and...
-
Global Regulatory Affairs Project Lead
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full time**About the Role**We are seeking a highly skilled Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. This role is responsible for developing and executing the EU/ROW regulatory strategy for assigned projects, ensuring optimal regulatory oversight of clinical trial submission activities.**Key Responsibilities Include**Act as...
-
Director of Regulatory Affairs and Strategy Lead
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly experienced Senior Director, Regulatory Affairs Strategy-EU/RoW to join our Global Regulatory Affairs organization.Key ResponsibilitiesDevelop and execute EU/ROW regulatory strategies for assigned programs, aligning with global development and commercial goals.Lead a team of Regulatory Strategists, providing mentorship...
-
Senior Global Regulatory Affairs Strategic Lead
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleAs a Senior Global Regulatory Affairs Strategic Lead at Genmab, you will be part of our Global Regulatory Affairs organization, playing a crucial role in shaping our regulatory strategy. Based in Copenhagen, Denmark, this hybrid position requires on-site presence 60% of the time.Job DescriptionThis is an exceptional opportunity to lead highly...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeSenior Director, Regulatory Affairs Strategy-EU/RoW Genmab is seeking a highly experienced and skilled Regulatory Affairs leader to join our Global Regulatory Affairs organization. This key role will be responsible for the development of global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products. The...
-
Senior Regulatory Affairs Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob SummaryGenmab seeks a highly skilled and experienced Senior Regulatory Affairs Specialist to join its Global Regulatory Affairs organization. As a key member of the team, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects. Your expertise in EU regulatory mechanisms and prior experience working with the...
-
Regulatory Affairs Strategist
1 month ago
Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full time**About the Role**We are seeking a seasoned Senior Regulatory Scientist to spearhead our regulatory affairs efforts in the Nordic region. This is an excellent opportunity for individuals who thrive in dynamic environments and are passionate about driving innovation in Life Science.**Responsibilities:**Develop and execute regulatory strategies for assigned...
-
Transformational Regulatory Affairs Leader
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're driven to revolutionize cancer treatment and serious diseases through pioneering therapies. As a Senior Director, Regulatory Affairs Strategy-EU/RoW, you will be part of our Global Regulatory Affairs organization.The RoleYou will develop global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed...
-
Regulatory Lead for EU and ROW Projects
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob Description:We are seeking an experienced Regulatory Lead to join our team in Copenhagen, Denmark. This is a full-time position that will report to the EU/ROW Regulatory Strategy Team Lead.About the Role:The successful candidate will be responsible for representing RA in the Clinical Trial Teams and ensuring oversight and progress of multiple clinical...
-
EU/ROW Regulatory Lead and Project Manager
2 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...
-
Regulatory Affairs Expert
2 months ago
Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full timeSenior Regulatory Scientist RoleWe are continuing to grow our Nordic business and are now seeking a Senior Regulatory Scientist. This role is suitable for those who are excited at the pace of change and innovation in Life Science, who want to partner with cutting-edge clients and continuously learn, develop, and progress personally and professionally.Key...
-
Senior Director of EU/ROW Regulatory Affairs
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly experienced Senior Director to lead our EU/ROW Regulatory Affairs team. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.Key...
-
Senior Regulatory Affairs Lead
2 months ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleGenmab is seeking a Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization.Key ResponsibilitiesRepresent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.Work closely with the CRO and internal stakeholders to ensure...
-
Senior Regulatory Affairs Manager
1 month 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...
-
Medical Device Regulatory Affairs Expert
1 month ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeJob Summary: We are seeking a highly skilled Medical Device Regulatory Affairs Specialist to join our team. As a key member of our Clinical and Regulatory team, you will play a critical role in maintaining superior product quality and ensuring compliance with regulatory requirements.About Us: At Radiobotics, we are driven by aspiration, curiosity, and...
-
Senior Regulatory Affairs Director
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Role:Genmab is seeking a highly skilled Senior Regulatory Affairs Director to join our Global Regulatory Affairs organization. This role will be responsible for representing RA in Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.Key Responsibilities:Represent RA in Clinical Trial...
-
Strategic Director, Regulatory Affairs Expert
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we are dedicated to creating extraordinary futures by developing pioneering antibody products and therapies that transform the lives of patients with cancer and serious diseases. Our commitment to innovation and science is rooted in our people who are caring, candid, and impact-driven.The Role We are seeking an experienced leader to join our...
-
Strategic EU/ROW Regulatory Affairs Director
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Role\Genmab, a leading biotechnology company, is seeking an experienced Senior Director to lead its Global Regulatory Affairs organization. Located in Copenhagen, Denmark, this role offers a unique opportunity to shape the company's regulatory strategy and drive innovation in cancer treatment.\The successful candidate will be responsible for...
-
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeWe are seeking an experienced Clinical Quality Assurance and Regulatory Affairs Specialist to join our team at Radiobotics ApS. The ideal candidate will have a strong background in quality assurance and regulatory affairs within the medical device industry.About the JobAs a Clinical Quality Assurance and Regulatory Affairs Specialist, you will play a key...