Strategic Director, Regulatory Affairs Expert
1 month ago
At 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 Global Regulatory Affairs organization. As a Senior Director, you will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products. You will provide strategic input and ensure operational execution of global submission activities. Direct interfacing with the European Medicines Agency (EMA) as the primary contact for assigned programs and oversight of regulatory Contract Research Organizations (CROs) for territories outside Japan and the US are key responsibilities.
This position is based in Copenhagen, Denmark, with onsite presence required 60% of the time. As a Strategic Director, you will assume responsibility for the EU/ROW regulatory strategy for assigned programs and manage a team of Regulatory Strategists with EU/ROW responsibilities across all stages of development.
Key Responsibilities:
- Managerial/supervisory responsibilities
- Actively mentor regulatory strategists with EU/ROW responsibilities
- Develop global regulatory strategies through integration of regional strategies and alignment with global development and commercial goals
- Lead or be responsible for planning and implementation of regional procedures, including clinical trial applications, marketing authorizations, label extensions, CMC changes, and PIPs
- Represent Regulatory Affairs across Genmab committees
- Evaluate and communicate regulatory risks and challenges, along with mitigation options, to senior management
- Oversee CRO quality, accountabilities, and deliverables related to Regulatory activities
- Assess EU and MHRA regulatory guidelines and regulations, and their impact on product development
- Interact with health authorities and lead/participate in health authority meetings
- Present the regulatory strategy/position to senior management and health authorities, as appropriate
- Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs
The successful candidate should have a minimum of a Bachelor's degree in a scientific discipline or health-related field. A PhD or MD degree is preferred. The ideal candidate should have at least 10 years of experience in Regulatory Affairs, across all development phases, with significant experience in planning and implementing complex clinical submission strategies.
Experience in leading a team of regulatory strategist professionals, expertise in drug development, and EU regulatory mechanisms to expedite development are essential. Prior experience leading health authority meetings with the EMA or other health authorities, submitting and bringing to completion Marketing Authorization Applications (MAAs) in Europe/ROW, and experience with variation procedures are highly desirable.
Additionally, the successful candidate should possess strong project management skills, organizational, communication, and time management skills, with the ability to run multiple ongoing projects simultaneously. Attention to detail and problem-solving skills are crucial, as well as the ability to work independently, drive projects to successful outcomes, and collaborate with cross-functional teams.
In terms of compensation, we estimate a salary range of $160,000 - $200,000 per year, depending on experience, with additional benefits and perks. If you are passionate about transforming the lives of patients with cancer and serious diseases, and you bring rigor and excellence to your work, we encourage you to apply for this exciting opportunity.
-
Strategic EU/ROW Regulatory Affairs Director
2 months 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...
-
Senior Regulatory Affairs Director
4 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...
-
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...
-
Regulatory Affairs Director
1 month ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout GenmabWe are a global biotechnology company dedicated to creating innovative antibody therapies that transform lives. Our passionate team of experts is driven by a shared purpose: to improve patient outcomes through cutting-edge science and collaboration.Job OverviewWe seek an experienced Director/Associate Director, Regulatory Affairs CMC to join our...
-
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...
-
Strategic Regulatory Affairs Director
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab OverviewGenmab is an international biotechnology company with a mission to develop innovative cancer treatments. With over 20 years of experience, the company has established a strong reputation for its next-generation antibody technology platforms and translational research. Genmab's passionate team is committed to transforming the lives of patients...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab.Job DescriptionIn this role, you will be responsible for representing RA in Clinical Trial Teams and ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW. You will also work closely with CROs and...
-
Global Regulatory Affairs Director
1 week ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeAbout Ferring PharmaceuticalsFerring Pharmaceuticals A/S is an innovative company that empowers employees to achieve excellence together. Our mission is to help people around the world build families and live better lives.Job Description: Global Regulatory Affairs Director - Small MoleculesThe ideal candidate will be responsible for leading CMC regulatory...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're committed to pushing the boundaries of innovation in the development of antibody products and pioneering therapies for cancer treatment and serious diseases.The role you'll be playing is pivotal in driving our vision forward. As a Director of Global Regulatory Affairs and Product Development, you will be responsible for overseeing...
-
Global Regulatory Affairs Strategist
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're 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. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
-
Copenhagen, Copenhagen, Denmark JUST EAT ApS Full timeAbout UsWe are a leading food delivery company, shaping the future of the industry with innovative solutions.Job OverviewWe are seeking an experienced Strategic Communications and Public Affairs Director to join our team in Denmark. This is a unique opportunity to drive our corporate reputation and public affairs strategy, working closely with stakeholders...
-
Director of Regulatory Affairs Process Excellence
2 months ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark / Danaher is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. To support this vision, we seek a highly skilled Director of Regulatory Affairs Process Excellence to join our team.The estimated salary for this position is $120,000 - $180,000 per year, depending on qualifications and experience.Job...
-
Regulatory Affairs Expert
1 week ago
Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full timeWe are seeking a talented Regulatory Affairs Expert to join our team at Voisin Consulting SARL. This role will be responsible for developing and executing regulatory strategies for assigned projects, including the preparation and submission of regulatory filings.Key Responsibilities:Develop Regulatory Strategies: Create and implement effective regulatory...
-
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 Ferring Pharmaceuticals AS Full timeUnlock Your Expertise as a Regulatory Affairs SpecialistFerring Pharmaceuticals A/S is dedicated to advancing innovative therapies for the treatment of diseases within Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas. As a Regulatory Affairs Specialist, you will play a crucial role in driving the development of our current and...
-
Transformational Regulatory Affairs Leader
4 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...
-
Copenhagen, Copenhagen, Denmark JUST EAT ApS Full timeAs a leading player in the food delivery industry, Just Eat ApS is embarking on an exciting new chapter. We are seeking a highly skilled Public Affairs and Corporate Communications Manager to join our team in Denmark.This role offers a unique opportunity to shape the company's public affairs and corporate communications strategy, driving business growth and...
-
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...
-
Leadership Role in Global Regulatory Affairs
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the PositionGenmab is seeking an experienced Senior Director to lead our Global Regulatory Affairs organization. As a key member of our team, you will be responsible for developing and executing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.Key Responsibilities:Develop and implement...
-
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...
