Global Regulatory Strategy Manager

About the RoleGenmab is seeking a talented and experienced Regulatory Affairs professional to fill the position of Sr. Director - Global Regulatory Strategy. This role offers a unique opportunity to work with a dynamic and innovative biotechnology company, contributing to the development and delivery of novel antibody therapeutics.In this capacity, you will...

At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued...

Key ResponsibilitiesDevelop and execute 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...

Job SummaryAs a Regulatory Manager in our Global Affairs department, you will be responsible for supporting the Global Regulatory Lead and/or Regional Regulatory Lead in the preparation of regulatory documentation and submissions to health authorities.You will work closely with cross-functional teams to ensure timely input and delivery of high-quality...

Genmab A/S is looking for a highly motivated and experienced Regulatory Manager to join our Global Affairs team. In this role, you will be responsible for supporting the Global Regulatory Lead and/or Regional Regulatory Lead in the preparation of regulatory documentation and submissions to health authorities.You will work closely with cross-functional teams...

Job SummaryWe are seeking a highly skilled Senior Manager to lead our Regulatory Affairs team in driving process improvements and implementing systems and tools to support efficient regulatory support. As a key member of the Global Regulatory Affairs team, you will be responsible for overseeing a team of highly engaged associates and focusing on their...

About the PositionWe are seeking an experienced Associate Director to join our Global Regulatory Affairs organization as EU/ROW Regulatory Lead. In this role, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects.Your Key AccountabilitiesDevelop and implement EU/ROW regulatory strategies to ensure compliance...

Key ResponsibilitiesRepresent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of multiple clinical trial submission activities.Develop and execute the EU/ROW strategy for assigned projects.Lead the preparation of strategic regulatory documents, including Briefing Packages, ODDs, PIPs, etc.Plan, prepare and lead EMA or national...

We are looking for an exceptional Global Regulatory Affairs Manager to join our team. This individual will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects, representing RA in the Clinical Trial Teams, and ensuring progress of multiple clinical trial submission activities.The Role & DepartmentThis position...

Job OverviewLeverage your expertise in global rewards and compensation to drive strategic growth at LEO Pharma.We are seeking a seasoned Global Rewards Strategy Manager to join our dynamic team. As a key member of our Global Rewards team, you will be responsible for developing and implementing equity compensation strategies, conducting global remuneration...

We are seeking an experienced Director of Regulatory Affairs to join our team at Black Swans Exist. As a key member of our organization, you will play a crucial role in shaping the future of women's health.Job DescriptionIn this challenging and rewarding role, you will be responsible for driving the regulatory framework for clinical development, Phase 2, and...

Key ResponsibilitiesDevelop global regulatory strategies through integration of regional regulatory strategies and alignment with global development and commercial goalsLead or be responsible for planning and implementation of regional regulatory procedures (e.g., clinical trial applications, marketing applications, label extensions)Represent Regulatory...

As an Associate Director, Global Regulatory Affairs Project Lead at Genmab, you will play a key role in ensuring the successful execution of clinical trials in the EU and ROW regions. In this position, you will be responsible for representing RA in the Clinical Trial Teams and working closely with the CRO and internal stakeholders to ensure regulatory...

About the RoleWe are seeking an experienced Regulatory Expert to join our Global Regulatory Affairs team. In this role, you will be responsible for supporting the Global/Regional Regulatory Lead in preparing regulatory documents and submissions to health authorities.You will work closely with cross-functional teams to ensure timely input and delivery of...

Genmab A/S is a biotechnology company that aims to transform the lives of people with cancer and other serious diseases through innovative and differentiated antibody therapeutics. Our team has developed a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and...

Your QualificationsA minimum of Bachelor's degree or equivalent in a scientific discipline or health-related fieldMinimum 10 years of experience in Regulatory Affairs across all development phasesSignificant experience in proactively planning and implementing complex clinical submission strategiesLeadership experience in Regulatory Affairs, including team...

We're committed to transforming lives through innovative antibody therapeutics at Genmab, and we need passionate individuals like you to help drive this mission forward.Director/Associate Director, Global Regulatory Affairs - CMCThis is a unique opportunity for a skilled Global Biologics Regulatory Professional to join our Regulatory Affairs CMC team and...

Job DescriptionWe are looking for a skilled Director/Associate Director to join our Regulatory Affairs CMC team in Copenhagen, Denmark.You will be responsible for operational and strategic regulatory CMC input to support worldwide development and commercialization of biological products. Your main duties will include developing and executing sound global...

At Genmab, we're dedicated to developing innovative antibody therapies that transform the lives of patients. Our passionate team of experts is committed to building extraordinary futures together, by pioneering cutting-edge treatments for serious diseases.The Role & Department We're seeking a highly skilled Regulatory Affairs Project Lead to join our Global...

As a Senior Manager at Radiometer Danmark / Danaher, you'll have the opportunity to make a significant impact on our Regulatory Affairs function. We're seeking an experienced professional to drive process improvements and implement systems and tools to support efficient regulatory support for the organization and growth of the company.This position is part...