Regulatory Affairs Specialist
5 days ago
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.
At AGC Biologics, you will get a unique opportunity working with a variety of state-of-the-art technologies among +40 different nationalities.
This opens many doors for personal development and for you to make a real difference towards both patients, customers, and your own development.
AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work.
We respect each other and our differences.
AGC employees are flexible and take pride in working together to achieve goals - as one team.
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork.
Our core values stem from our team members and are embedded into our DNA.
They provide a common language and understanding of how we as an organization are connected across three continents.
Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
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CMC Regulatory Affairs Specialist
1 hour ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. As a key member of our regulatory affairs department, you will provide strategic, tactical, and operational regulatory input to projects. Your responsibilities will include...
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Senior Regulatory Affairs Specialist
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full timeCome work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - Senior Regulatory Affairs Specialist (2507030367W) Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands —...
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Regulatory Affairs Professional, RA Obesity
7 days 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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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Description:The Director of Regulatory Affairs for CMC Biologics will lead the development and execution of regulatory strategies for biologics and rare diseases. This role requires a seasoned leader with extensive experience in regulatory affairs, able to inspire and empower teams to deliver high-quality results.Key Responsibilities:Develop and execute...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeDirector of Regulatory Affairs for CMC Biologics & Rare Diseases Category: Project Management & Agile Location: Søborg, Capital Region of Denmark, DK Are 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...
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Regulatory Affairs Manager
4 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the DepartmentDigital Transformation is a department placed in RQ&C: RQ&C consists of the four functional areas: Regulatory Affairs (approvals by health authorities), R&D Quality (ensuring quality and compliance), Clinical Reporting (medical writing) and Digital Transformation (driving the Digital agenda). Furthermore, our department also supports the...
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Data-Driven Regulatory Affairs Professional
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a talented Senior Regulatory Business Analyst to join our dynamic team at Novo Nordisk A/S. As a key member of the Regulatory Affairs department, you will play a critical role in driving business analysis and process improvements across the organization.Your primary responsibilities will include:Business Analysis: Identify...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeThe Ideal CandidateWe are looking for an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. The ideal candidate will have a Master's and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health...
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Regulatory Affairs Process Excellence Manager
11 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleNovo Nordisk A/S is seeking an experienced Regulatory Affairs Process Excellence Manager to join our RA Process and Digital Strategy area. As a key member of the team, you will play a central role in driving process excellence, innovation, and digital transformation across the regulatory affairs organization at a corporate level and across all...
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CMC Regulatory Specialist
5 hours 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 Director
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Description:We are seeking an experienced leader to join our team as the Director of Regulatory Affairs for CMC Biologics and Rare Diseases. As a key member of our leadership team, you will play a pivotal role in shaping the future of RA CMC. Your expertise in drug regulatory affairs will drive excellence in our pipeline and deliver regulatory approvals...
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Regulatory Business Optimization Specialist
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly skilled Senior Regulatory Business Analyst to join our team at Novo Nordisk A/S. As a key member of the Regulatory Affairs department, you will play a critical role in driving business analysis and process improvements across the organization.Your primary responsibilities will include:Business Analysis: Identify...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Summary:The Director of Regulatory Affairs for CMC Biologics will be responsible for developing and executing regulatory strategies for biologics and rare diseases. This role requires a highly experienced and visionary leader who can inspire and empower teams to deliver high-quality results.Key Challenges:Developing and executing global approval...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionThis role offers a unique opportunity to join a dynamic team in a fast-paced, global environment. As a CMC Regulatory Specialist, you will play a critical role in ensuring the successful development and approval of our synthetic small molecule projects. Your expertise in regulatory affairs, combined with your knowledge of synthetic small...
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Regulatory Compliance Solutions Professional
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the TeamThe RA Process and Digital Strategy area within Regulatory Affairs is a growing team of 10 people, committed to securing process excellence and digital innovation to reach more patients faster.We work across the value chain from early development to product discontinuation, ensuring medicine availability to patients. Our team is based at our...
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Regulatory Affairs Manager
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob SummaryWe are looking for a highly motivated and detail-oriented Compliance Engineer to join our team. As a Compliance Engineer, you will play a key role in ensuring that our facilities and processes meet regulatory requirements.About the PositionYou will be part of the Plant Engineering department, responsible for implementing and maintaining quality...
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External Affairs and Advocacy Expert
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Unique Human Capital AS Full timeKey Responsibilities and SkillsThe Governmental Public Affairs & Communications Head at Merck will be responsible for:Developing and implementing strategic engagement plans to build coalitions with external stakeholders. Monitoring legislative and regulatory developments. Engaging with government officials and policymakers. Managing public policy matters....
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Senior Regulatory Data Analyst
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the TeamThe RA Process and Digital Strategy area within Regulatory Affairs is a growing team of 10 people. We are committed to securing process excellence and digital innovation to reach more patients faster by standardising ways of working with a focus on end users.Our mission is to make work easier and more rewarding for our colleagues. In Regulatory...
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Government Affairs and Communications Lead
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Unique Human Capital AS Full timeAbout the RoleThe Governmental Public Affairs & Communications Head will be responsible for developing and implementing strategic engagement plans to build coalitions with external stakeholders. This includes monitoring legislative and regulatory developments, engaging with government officials, and managing public policy matters.Key...
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Regulatory Business Insights Analyst
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a talented Senior Regulatory Business Analyst to join our team at Novo Nordisk A/S. This role is an exciting opportunity to work with diverse data from various core systems, driving analysis, performance, and insights to enable optimal decision making across business units.The successful candidate will be responsible for...