Senior Regulatory Specialist
2 weeks ago
- Contribute regulatory expertise to global strategies and tactics
- Develop regulatory documentation for submission to Health Authorities globally, e.g., clinical trial applications, briefing packages, paediatric plans, and responses to health authority questions
- Represent Global Regulatory Affairs in global clinical trial teams and other cross-functional teams
- Collaborate effectively with cross-functional stakeholders such as project managers, medical and non-medical specialists, statisticians, and medical writers
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Regulatory Data Specialist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAt 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...
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CMC Regulatory Specialist
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect 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...
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Regulatory Affairs Specialist
3 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeCompany OverviewNovo Nordisk A/S is a dynamic company in the pharmaceutical industry, driven by innovation and a commitment to patient care. We strive for excellence without fixating on perfection, embracing experimentation and seizing opportunities for growth.Job DescriptionWe are seeking an experienced Regulatory Affairs Specialist to join our Device and...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAt 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...
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Regulatory Affairs Strategist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout 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...
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Regulatory Affairs Professional, RA Obesity
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect 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...
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Regulatory Compliance Expert
1 week ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout Our TeamWe are a diverse and inclusive team of professionals dedicated to delivering high-quality products and services. Our team is passionate about innovation and quality, and we are committed to creating a culture of excellence.We are seeking a Senior Quality Assurance Specialist to join our CMC API QA team. In this role, you will be responsible for...
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Global Regulatory Lead
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout 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...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob 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...
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Regulatory Affairs Specialist in CVD/CKD Area
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob 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...
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Regulatory Compliance Specialist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeDigital Health & Staffs Quality DepartmentOur department is responsible for ensuring the quality and integrity of our digital health products and processes. We are a collaborative and dynamic team that values innovation and continuous improvement. As a Senior QA Professional, you will play a critical role in helping us achieve our goals and objectives.Key...
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Regulatory Compliance Specialist
1 day ago
Gladsaxe, Gladsaxe Municipality, Denmark Reckitt Benckiser Full timeReckitt 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...
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Regulatory Compliance Expert
1 day ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeOur 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...
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Regulatory Affairs Expert
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout 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...
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Biologics Regulatory Affairs Expert
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeGlobal 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...
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Head of Regulatory Business Alliances
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeKey Responsibilities">This role requires a high level of leadership, utilizing communication prowess across organizational tiers, and fostering valuable professional networks that include external collaborations. The ideal candidate will have a keen analytic mindset, identifying value-critical paths and planning future projects.You will collaborate with the...
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CMC Regulatory Affairs Expert
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAt 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...
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Regulatory Document Expert
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAs a Medical Writing Specialist, you will represent Clinical Reporting as a strategic partner in a dynamic environment. You will plan and prepare a broad range of regulatory documents, engage and influence strategic project decisions, and act as a project manager.Key responsibilities include leading tasks such as planning, development, and oversight of...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeWe'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...
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Regulatory Affairs Process Strategist
1 day ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout UsWe are a global pharmaceutical company committed to creating innovative solutions for better lives.Our Regulatory Affairs team plays a crucial role in ensuring the safe and effective use of our products.Job DescriptionKey Responsibilities:Develop and implement process strategies to drive excellence in regulatory affairsManage cross-functional...