Regulatory Affairs Director
2 months ago
The Regulatory Affairs CMC team at Genmab is seeking a Director/Associate Director to support worldwide development and commercialization of biological products. The ideal candidate will have a strong understanding of compliance and biologics, with a track record of moving therapeutic products through various stages of development.
Key Responsibilities:
- Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.
- Collaborate with cross-functional peers to facilitate and optimize product development.
- Plan, review, and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
- Provide advice and guidance on EU, US, and selected worldwide regulatory legislation for CMC topics.
- Evaluate and communicate regulatory risks and challenges.
- Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities.
Requirements:
- Master of Science in pharmacy, engineering, or equivalent.
- Minimum of 8+ years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics.
- A track record in moving therapeutic products through various stages of development.
- Experience with preparation of BLAs and preferably experience with lifecycle management.
- Proficient communication in English (verbal and written).
About Genmab:
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences.
Our commitment to diversity, equity, and inclusion:
We are committed to fostering workplace diversity at all levels of the company and we 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.
-
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...
-
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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs CMC team. This is an exciting opportunity to work in a dynamic and innovative environment, collaborating with talented colleagues in Regulatory Affairs and within Genmab's CMC organization.Key...
-
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...
-
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 Director
3 weeks 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...
-
Strategic Director, Regulatory Affairs Expert
3 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...
-
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 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 Expert
1 month ago
Copenhagen, Copenhagen, Denmark WSAudiology Full timeAt WSAudiology, we're navigating a rapidly evolving regulatory landscape and seeking a Global Senior Regulatory Affairs Specialist to join our team.This pivotal role will ensure that our products meet the highest standards of compliance. As a key member of our global Regulatory Affairs team, you'll be integral to day-to-day regulatory problem-solving and...
-
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...
-
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...
-
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 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...
-
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...
-
Global Regulatory Affairs CMC Strategist
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeOverviewGenmab, a dynamic and innovative biotechnology company, is seeking an experienced Associate Director to join its Global Regulatory Affairs CMC team. This role offers an exciting opportunity to contribute to the development and commercialization of biological products worldwide.
-
Strategic Regulatory Affairs Director
1 week 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 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 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...
-
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...
