Regulatory Affairs Project Coordinator

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to develop and execute the late-stage regulatory strategy for a key project. This role requires strong scientific knowledge and regulatory expertise to evaluate strategies, manage multiple regulatory tasks with overlapping timelines, and collaborate closely with Global Regulatory...

Select how often (in days) to receive an alert: Create AlertExpert in Regulatory Affairs - Primary PackagingCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKAre you ready to take on new challenges in primary packaging development across emerging therapeutic areas and innovative products? Would you like to use...

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 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...

About UsWe are committed to securing process excellence and digital innovation to reach more patients faster by simplifying and standardizing ways of working with a focus on end users. Our Regulatory Affairs team manages submission, registration, and labelling to obtain authority approval for all Novo Nordisk products. We work across the value chain from...

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...

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...

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...

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...

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 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...

We are recruiting for a Regulatory Affairs and Clinical Trials professional to join our team at Novo Nordisk A/S. As a Global Trial Manager, you will play a critical role in ensuring the quality and integrity of our clinical trials.Key responsibilities include:Ensuring compliance with regulatory requirements, good clinical practices, and internal...

About UsNovo Nordisk A/S is a world-leading biopharmaceutical company with over 90 years of experience in delivering innovative medicines that improve the lives of people with diabetes and other serious chronic conditions. Our mission is to create value for patients, customers, and shareholders through sustained growth, customer satisfaction, and operational...

Director of Regulatory Affairs for CMC Biologics & Rare DiseasesCategory: Project Management & AgileLocation: Søborg, Capital Region of Denmark, DKAre you an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs? Do you excel in a dynamic environment and want to be part of a rapidly growing...

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...

Global Regulatory CMC Leadership RoleAbout Our CultureWe recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.About the JobWe are seeking a highly...

Director of Regulatory Affairs for CMC Biologics & Rare DiseasesAbout the PositionThe RA CMC organization is growing, and we are strengthening our leadership team with a new Director with strong experience and interest in Regulatory Life Cycle Management. As the Director for RA CMC Biologics & Rare Diseases, you will play a pivotal role in shaping the future...

We are looking for a dynamic and visionary leader to spearhead our team as the Director of Regulatory Affairs for Biologics and Rare Diseases.About the positionThe RA CMC organization is growing, and we are strengthening our leadership team with a new Director with strong experience and interest in Regulatory Life Cycle Management.Be accountable for the...

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...

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...