Regulatory Document Expert

The RoleWe are looking for a highly skilled Regulatory Document Manager to join our Clinical Reporting team at Novo Nordisk. In this role, you will be responsible for leading the preparation of complex clinical documents and acting as a project manager.You will work closely with other job functions across Development, ensuring all source information and data...

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 OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in innovative development within rare diseases.This is an exciting opportunity to become part of a fast-changing field where no two days are alike.The PositionAs a Regulatory Specialist, you will be responsible for setting the regulatory strategic direction in...

Our TeamDigital Health & Staffs Quality consists of a group of engaged and motivated QA Specialists and Project Managers. We are QA-responsible for global Digital Health projects and solutions, acting as a Digital Health Quality Competency Center for Novo Nordisk worldwide. Additionally, we are QA-responsible for Novo Nordisk processes within Customer...

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 DescriptionThe position involves providing strategic regulatory input, assessing risks, and developing mitigation strategies. Key responsibilities may include:Representing Global Regulatory Affairs in various cross-functional teams.Planning, preparing, and leading Health Authority interactions.Developing regulatory documents, including briefing packages,...

What We OfferWe offer a dynamic and supportive work environment, where you will have the opportunity to work with a talented team of professionals.As a Regulatory Compliance Expert at Novo Nordisk A/S, you will have access to training and development opportunities, and the chance to make a real difference in the lives of patients through the development of...

Navigating Complex Regulations to Drive Business SuccessIn this dynamic role, you will leverage your expertise in regulatory affairs to drive business growth and expansion while ensuring compliance with product safety standards and regulatory requirements in Nordic markets. As a Regulatory Affairs Associate in our Hygiene division, you will develop and...

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...

About Novo NordiskWe're a dynamic company in the biopharmaceutical industry, dedicated to driving innovation and making a meaningful impact on patient care.Our commitment to excellence is evident in our research and development efforts, where we strive to move the needle on therapeutic areas like obesity.The RoleWe're seeking a skilled Regulatory Affairs...

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...

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...

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...

About the RoleThis position is a unique opportunity to drive strategic initiatives and contribute to the rapid development of a high-impact program.As a Senior Regulatory Professional, you will work within the RA Obesity therapeutic area in one of our key projects, which is progressing rapidly towards End-of-Phase 2 interactions and initiation of a large...

Job RequirementsQualifications and SkillsTo be a competitive candidate, you should have:A master's degree within life sciences with 6-8 years of relevant experience and/or a relevant PhD with 4-5 years of relevant documented working experienceExperience in preparing and delivering on global regulatory strategies, including employment of expedited and...

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...

Job Title: Global Regulatory Lead in CVD/CKD Area - Strategic ExpertWe are seeking a highly skilled and experienced professional to join our team as a Global Regulatory Lead. As a key member of our cross-functional project teams, you will be responsible for driving regulatory strategies and executing various regulatory tasks.The successful candidate will...

Reckitt Benckiser is a global leader in hygiene, health, and nutrition products. Our purpose drives our actions: to protect, heal, and nurture people around the world.About the RoleWe are seeking a highly skilled Regulatory Affairs Associate to join our team in Hygiene. As a key member of our regulatory team, you will be responsible for ensuring compliance...

At Novo Nordisk A/S, we are expanding our product and project pipeline in a fast-paced, dynamic environment.We are 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 in the RA CMC Biotech & Rare Disease area.The ideal...

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...