Senior Regulatory Affairs Manager
1 month ago
Genmab 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 pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
We are committed to fostering a workplace diversity at all levels of the company and believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
As Senior Regulatory Affairs Manager, you will have the opportunity to work in a fast-growing, dynamic company and contribute to the overall success of Genmab. You will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple, often highly complex, clinical trial submission activities. You will also act as EU/ROW Regulatory Lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW regulatory strategy.
The ideal candidate will have a minimum of Bachelor's degree or equivalent in scientific discipline or health-related field, with a minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications. You should have experience in proactively planning and executing highly complex clinical submission strategies and prior experience leading health authority meetings with the EMA or other health authorities.
In this role, you will be part of our Global Regulatory Affairs organization and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial submissions in EU/ROW. You may also be allocated as EU/ROW Regulatory Strategy Lead to one or multiple compounds in early or late development and provide regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team.
The estimated salary for this position is DKK 1,200,000 per year, based on industry standards and location. As an employee of Genmab A/S, you will enjoy a competitive benefits package, including comprehensive health insurance, flexible working hours, and opportunities for professional growth and development.
If you are passionate about our purpose and genuinely care about our mission to transform the lives of people with cancer, we encourage you to apply for this exciting opportunity. Please submit your application, including your resume and cover letter, to us.
-
Senior Regulatory Affairs Manager
1 month ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeTransform the lives of patients with innovative cancer treatment by joining our dynamic team at Genmab A/S as a Senior Regulatory Affairs Manager for Biological Products.About the RoleWe are seeking a seasoned professional to lead our regulatory affairs efforts in the CMC department. As a Senior Regulatory Affairs Manager, you will be responsible for...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Regulatory Affairs Senior Manager
2 months ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeIn a world where life is precious, our technology and solutions empower caregivers to make informed decisions that improve patient care.At Radiometer Danmark/Danaher, our purpose is to unite over 4000 colleagues worldwide in a shared goal. We create impactful innovations that require persistence, passion, and a desire to make a difference.The Senior Manager,...
-
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeAt Radiometer Danmark / Danaher, we're committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We're seeking a highly skilled Senior Manager, RA Processes, Systems and Tools to join our team.The ideal candidate will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs...
-
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 Full timeAbout the RoleWe are seeking a highly skilled Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization. The successful candidate will be responsible for representing RA in Clinical Trial Teams and ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW.
-
Regulatory Affairs Consultant
1 month ago
Copenhagen, Copenhagen, Denmark VCLS Full timeSenior Regulatory Scientist RoleWe are expanding our business and seeking experienced Senior Regulatory Scientists to work with cutting-edge clients in the Life Sciences industry.This consulting role is ideal for individuals who bring deep regulatory expertise, have commercial acumen, and can provide strategic advice and build strong client relationships.The...
-
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...
-
Global Regulatory Affairs Leader
1 month ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeTransformative Leadership OpportunityWe are seeking an exceptional Global Regulatory Affairs leader to join our team at Genmab A/S, a pioneering biotechnology company dedicated to revolutionizing cancer treatment. As a seasoned expert in regulatory affairs, you will play a pivotal role in shaping the strategic direction of our global regulatory programs and...
-
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...
-
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...
-
Copenhagen, Copenhagen, Denmark WSAudiology Full timeWS Audiology is at the forefront of the medical device industry, navigating a rapidly evolving regulatory landscape.As a pivotal role in our company, we're seeking a Global Senior Regulatory Affairs Specialist to join our team.In this HQ-based position, you will be integral to ensuring that our products meet the highest standards of compliance.Your mission...
