Global Regulatory Coordination

About the TeamRA Obesity is a new and expanding area within Global Regulatory Affairs consisting of 20 dedicated and highly engaged Global Regulatory Leads, Regulatory Specialists, and Professionals, organised in two teams.We are responsible for developing and executing on global regulatory strategies, designed to advance projects across multiple...

Novo Nordisk A/S: Where Passion Meets PurposeWe're a global leader in diabetes care and biopharmaceuticals, driven by a passion for improving lives. Our mission is to make a meaningful difference for people with chronic conditions, and we need talented individuals to join our team and help us achieve this goal.Role OverviewWe're seeking an experienced...

Key ResponsibilitiesRepresent QC Chemistry in Customer project teams and internal AGC QC analytical teamsCoordinate and plan analytical QC activities, ensuring timely completion of projects and tasksSupport clinical and commercial manufacturing for our Customers worldwide, maintaining close relationships with internal stakeholders and external vendorsDevelop...

Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Are you able to cut through complexity and drive regulatory strategies for high impact projects? Would you like to work together with experts across multiple functions in a global environment? Do you want to be part of an exciting area where engaged people are...

About the Role:We are seeking a highly skilled Global Regulatory Lead to join our team in the Cardiovascular & Chronic Kidney Diseases (CVD/CKD) therapeutic area.As a Global Regulatory Lead, you will be responsible for developing regulatory strategies and executing various regulatory tasks within cross-functional project teams.You will lead the development...

Job Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team in the Cardiovascular & Chronic Kidney Diseases (CVD/CKD) therapeutic area. As a Global Regulatory Lead, you will be responsible for developing regulatory strategies and executing various regulatory tasks within cross-functional project teams.Your key...

Key ResponsibilitiesContribute regulatory expertise to global strategies and tacticsDevelop regulatory documentation for submission to Health Authorities globally, e.g., clinical trial applications, briefing packages, paediatric plans, and responses to health authority questionsRepresent Global Regulatory Affairs in global clinical trial teams and other...

Company Overview">At Novo Nordisk A/S, we strive to be a leader in diabetes care and innovative biopharmaceuticals. Our company has been committed to improving the lives of people with diabetes for more than 90 years.We are dedicated to developing innovative medicines that make a meaningful difference to patients' lives, from early discovery to late-stage...

We are looking for a talented and motivated individual to fill the role of Director of Regulatory Affairs for Biologics and Rare Diseases.About the responsibilitiesAs the Director for RA CMC Biologics & Rare Diseases, you will be responsible for leading and developing high-performing teams to achieve business objectives and deliver exceptional...

Key ResponsibilitiesAs a Regulatory Affairs Professional, you will be responsible for:Planning, coordinating and executing regulatory submissions.Creating, planning and coordinating submission timelines in collaboration with CMC subject matter experts (SME), affiliates and other key stakeholders.Defining and driving needed updates of the Quality (M3) drug...

Select how often (in days) to receive an alert: Create Alert Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you want to be part of a growing organization, contributing to the success of Novo Nordisk's expanding product portfolio? Are you passionate about regulatory guidelines and committed to ensuring...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Professional to join our RA CMC & Device team. As a key member of our organization, you will play a crucial role in ensuring the success of Novo Nordisk's expanding product portfolio.About the RolePlan, coordinate and execute regulatory submissions.Create, plan and coordinate submission...

Select how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you want to be part of a growing organization, contributing to the success of Novo Nordisk's expanding product portfolio? Are you passionate about regulatory guidelines and committed to ensuring...

We're committed to creating an inclusive culture that celebrates diversity and promotes equality of opportunity for all job applicants. At Novo Nordisk, we recognize that being the best company in the world is no longer good enough; we need to aspire to be the best company for the world.About the RoleAs a CMC Regulatory Specialist, you'll contribute to...

Select how often (in days) to receive an alert: Create Alert (Senior) Regulatory Affairs Professional, RA Obesity - Maternity cover Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you have a talent for navigating complex regulatory landscapes and driving strategic initiatives? Are you eager to contribute...

About the Department:The RA Cardiovascular & Chronic Kidney Disease department is responsible for contributing to the development of different products and projects within the cardiovascular and chronic kidney diseases field.Our department comprises 16 dedicated and highly engaged employees with diverse backgrounds and experience.We are looking for a Global...

Select how often (in days) to receive an alert: Create AlertRegulatory Affairs Business Development DirectorCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug development...

Select how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation: Søborg, Capital Region of Denmark, DKWe are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic...

At Novo Nordisk, we are expanding our product and project pipeline and seeking an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join the Synthetics & Cell Technologies Department. This role provides strategic, tactical, and operational regulatory input to projects.The...

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.Are you motivated by leading and participating in coordination and planning...