Regulatory Affairs Specialist for Synthetic Small Molecules

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...

Novo Nordisk is driving change in the industry by embracing experimentation and striving for excellence without fixating on perfection. We're a dynamic company in a fast-paced environment, working together to move the needle on patient care.Job DescriptionThis is an opportunity to work on synthetic small molecules, including process design, analytical...

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...

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...

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...

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...

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 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...

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...

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...

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...

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...

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...

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...

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...

At Novo Nordisk A/S, we're looking for a Regulatory Data Specialist to join our Digital Transformation team in RQ&C. As a key member of the department, you'll be responsible for implementing and supporting data governance across the organization.Your main responsibilities will include:Create and maintain master dataAnalyse and resolve data challenges, with...

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...

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...

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...