Global Regulatory

We are looking for a highly skilled Global Regulatory Lead to join our Regulatory Affairs CMC team at Genmab A/S. As a key member of our team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of global...

About the RoleIn this critical position, you will play a key role in driving regulatory strategy and ensuring compliance with global and local regulations. You will collaborate closely with internal stakeholders, including Global Regulatory Affairs, Supply Chain, QA, Market Access, Marketing, and Medical.The responsibilities of this role include leading...

Oresund Pharma ApS is a dynamic and ambitious company seeking a talented Global Regulatory Manager to join our Regulatory department.In this role, you will be responsible for ensuring that our products comply with regulatory requirements and commercial demands worldwide. This includes managing regulatory submissions, establishing relationships with...

Regulatory Director Job DescriptionTbwa Chiat/Day Inc is seeking a highly experienced and skilled Regulatory Director to join our team. This key regional leader will play a crucial role in shaping our regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing local market nuances.The ideal candidate will have...

Unlock the Potential of Regulatory AffairsGenmab A/S is seeking a highly experienced and skilled Global Regulatory Expert to join its team. As a key member of the Global Regulatory Affairs organization, you will play a crucial role in shaping the company's regulatory strategies and ensuring the successful execution of global submissions.About the RoleThe...

We are looking for an exceptional individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring regulatory compliance and oversight for our clinical trials.In this role, you will represent RA in Clinical Trial Teams and...

Job Overview:The Senior Director of Global Regulatory Affairs will lead Tbwa Chiat/Day Inc's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business objectives. This role involves overseeing the company's engagement with regulatory bodies, shaping public policy initiatives, and ensuring seamless...

Oresund Pharma is seeking a Regulatory Affairs Manager to lead our product registration efforts globally. As a key member of our Regulatory department, you will ensure the successful delivery of regulatory plans aligned with business priorities.Key Responsibilities:Oversee the regulatory lifecycle management of our product portfolio.Ensure product compliance...

We're seeking a talented and motivated Senior Director to lead our Regulatory Affairs function.In this role, you'll be responsible for developing global regulatory strategies for our portfolio of development pipeline candidate drugs and marketed products.You'll provide strategic input and ensure operational execution of global submission activities,...

Key ResponsibilitiesOversee and direct an awesome team of highly engaged associates and focus on continuous development of the team.Drive process improvements for RA owned processes and procedures.Implement systems and tools that support the Regulatory Affairs organization towards a more efficient way of working.RequirementsMinimum bachelor's degree in a...

About the JobWe are seeking a seasoned Regulatory Affairs professional to join our Global Regulatory Affairs team. As a Senior Director, you will be responsible for the development and implementation of EU/ROW regulatory strategies for Genmab's programs across all stages of development. You will work closely with cross-functional teams to ensure an optimal...

Key ResponsibilitiesProvide regulatory input and technical guidance on local regulatory requirements to product development teams.Assess the acceptability of quality, preclinical, and clinical documentation for submission filing to comply with applicable local Health Authority requirements.Prepare and submit regulatory submissions according to applicable...

About GenmabGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. We leverage translational research and data sciences to develop next-generation antibody technology platforms, including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced...

The Regulatory Director will serve as a key regional leader for the company's regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing the unique requirements of local markets. Acting as a bridge between the VP of Public Policy & Regulatory Affairs, other Regional Regulatory Directors, and local teams, this...

About the RoleWe are seeking an experienced Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. In this role, you will be responsible for leading the development and execution of the EU/ROW regulatory strategy for assigned projects.Key ResponsibilitiesAct as EU/ROW regulatory lead and EMA contact person for assigned...

About the RoleTbwa Chiat/Day Inc is seeking a highly experienced and skilled Regulatory Director to join our team. This key regional leader will play a crucial role in shaping our regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing local market nuances.The ideal candidate will have deep legal and...

About the Role:The Associate Director Regulatory Strategy will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. This role will represent EU/ROW in the Global Regulatory Team(s) and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Develop...

Role OverviewThe VP of Public Policy and Regulatory Affairs will lead the development of AstroPay's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business goals. This role will oversee the company's engagement with regulatory bodies, shape public policy initiatives, and ensure seamless...

Radiometer Danmark/Danaher is proud to work at the forefront of diagnostic innovation. Our shared purpose unites over 4000 employees worldwide in a pursuit to improve patient care through technology and solutions.We are seeking an exceptional individual to join our Global Regulatory Affairs team as Senior Manager, RA Processes, Systems and Tools.As part of...

At 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. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly unique,...