Synthetic Small Molecules Regulatory Role
3 days ago
As a CMC Regulatory Expertise Opportunity, you will be responsible for:
- Applying regulatory intelligence and establishing strategy for submission of clinical trial applications (CTAs) and marketing authorizations (MAAs)
- Submission of regulatory files and responding to questions from health authorities
- Ensuring the preparation, review, and submission of pre-meeting packages for health authority meetings as well as conducting rehearsals and participating in the meetings
- Addressing process challenges by performing analyses and proposing new ways to support projects
- Identifying phase-appropriate regulatory risks and developing mitigation strategies
- Performing the regulatory assessment of planned or implemented CMC changes based upon global regulatory guidelines
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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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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 Affairs CMC Professional
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist to join our Synthetics & Cell Technologies Department in the RA CMC Biotech & Rare Disease area within Novo Nordisk.The successful candidate will provide strategic, tactical, and operational regulatory input to projects, leading activities...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeQualificationsA Master and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health authority.A minimum of 8+ years of experience with synthetic small molecules experience is preferred, as well as experience in the following areas:In-depth knowledge of regulatory CMC requirements for clinical...
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CMC Regulatory Affairs Specialist
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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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CMC Regulatory Specialist
6 days 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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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK We 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 Chemistry Specialist
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob OverviewWe are seeking an experienced CMC Regulatory Specialist to join our team in Novo Nordisk A/S. As a key member of our regulatory affairs department, you will be responsible for providing strategic, tactical, and operational regulatory input to projects.The ideal candidate will have expertise in synthetic small molecules and experience working with...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleThis is an exciting opportunity for a motivated and experienced Regulatory Affairs Chemistry Specialist to join our team at Novo Nordisk A/S. As a CMC Regulatory Specialist, you will provide expert advice on regulatory requirements for clinical trial applications (CTAs) and marketing authorizations (MAAs).You will be responsible for ensuring...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeRequired Skills and QualificationsTo be considered for this role, you must possess:A master's degree and/or Ph.D., and a minimum of 10 years of experience from regulatory organisations within the pharmaceutical industry or from working at a Health Authority.Experience with global regulations and requirements, regulatory strategies, and projects.Experience...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionThe role of a Regulatory Affairs Specialist for Innovative Medicine Development in Rare Diseases involves driving regulatory strategies to obtain approvals for novel therapies.As a key member of our Global Regulatory Affairs team, you will work closely with cross-functional project teams to develop and implement regulatory plans that meet the...