Regulatory Affairs Director
1 month ago
About Genmab
We 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 Overview
We seek an experienced Director/Associate Director, Regulatory Affairs CMC to join our team in Copenhagen, Denmark. This exciting role will play a key part in shaping our regulatory strategy for biological products and collaborating with cross-functional teams to drive product development.
Responsibilities
- Develop and execute global regulatory strategies for biologics during early and late stage development, and lifecycle.
- Collaborate with peers to facilitate and optimize product development.
- Plan, review, and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
- In collaboration with CMC, plan and prepare responses to health authority information requests.
- 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's degree in pharmacy, engineering, or equivalent.
- Minimum 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).
What We Offer
- A competitive salary of approximately €120,000 per year.
- An exciting opportunity to work in a dynamic, global company collaborating with talented colleagues.
- A robust and supportive Regulatory Affairs CMC team fostering a culture of collaboration and mutual support.
- The position is based in Copenhagen, Denmark, and is hybrid.
About You
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do.
- You are a generous collaborator who can work in teams with diverse backgrounds.
- You are determined to do and be your best and take pride in enabling the best work of others on the team.
Genmab's Commitment to Diversity, Equity, and Inclusion
We are committed to fostering a workplace culture that values diversity, equity, and inclusion. We believe it is essential for our continued success and strive to create a workplace where everyone feels welcome, valued, and empowered to contribute their best work.
-
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...
-
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...
-
Strategic Director, Regulatory Affairs Expert
1 month 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...
-
Global Regulatory Affairs Director
2 weeks 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...
-
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...
-
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...
-
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...
-
Leadership Role in Global Regulatory Affairs
2 weeks 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...
-
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...
-
Strategic Regulatory Affairs Director
4 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 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 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...
-
Regulatory Affairs CMC Leader
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking an experienced Regulatory Affairs CMC Leader to join our team in Copenhagen, Denmark. As a key member of our Regulatory Affairs CMC team, you will be responsible for developing and executing global regulatory strategies for biological products during early and late-stage development and lifecycle.Key ResponsibilitiesDevelop and...
-
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...
-
Medical Device Regulatory Affairs Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeThe Hub/Danske Bank is seeking a highly skilled Medical Device Regulatory Affairs Specialist to join their Clinical and Regulatory team. This role will be responsible for ensuring that all medical devices developed by the company comply with regulatory requirements, such as MDR and ISO 13485.Job Description:Collaborate with cross-functional teams to develop...
-
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...
-
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark/Danaher is a leading company in the diagnostics industry, dedicated to improving global healthcare with reliable, fast, and easy patient diagnoses. As a Senior Manager, RA Processes, Systems and Tools, you will play a crucial role in driving process improvements and implementing systems and tools within Regulatory Affairs to support...
