Regulatory Affairs Expert for Rare Diseases and Innovative Developments
2 weeks ago
We 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 innovative development projects and highly scientific settings.
- Develop and execute regulatory strategies to obtain approvals
- Provide expert regulatory advice and tactics with a focus on development and business acumen
- Demonstrate subject matter expertise within regulatory science and global development projects
- Plan and drive regulatory activities and deliverables according to agreed timelines and quality
- Be accountable for specific deliverables such as submission and approval of clinical trial applications
- Coordinate preparation of meeting packages to Health Authorities, conduct Health Authority interactions
You will report to the Senior Director of RA Rare Bleeding Disorders and take an active part in department-related activities, including improvement projects across RA.
RequirementsTo be a competitive candidate, you should have:
- A master's degree within life sciences with 6-8 years of relevant experience or a relevant PhD with 4-5 years of documented working experience
- Experience in preparing and delivering global regulatory strategies, employing expedited and accelerated pathways across major regulatory agencies globally, and handling regulatory documentation for pharmaceutical development
- Strong knowledge of the pharmaceutical industry and experience interacting directly with regulatory authorities internationally
- Experience within rare disease is an advantage
- Strong negotiation skills and sound business understanding
- Professional proficiency in English
The RA Rare Bleeding Disorders department is part of Global Regulatory Affairs and located in Denmark.
We contribute to the development of various products and projects within Rare Bleeding Disorders with a pipeline including different modalities and technologies.
Career at Novo NordiskWe don't wait for change; we drive it. We're a dynamic company in a dynamic industry, and we know that what got us here may not be what will make us successful in the future.
We strive for excellence without fixating on perfection.
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeOverviewJob Title: Regulatory Affairs Specialist for Rare Disease DevelopmentThe Novo Nordisk A/S RA Rare Bleeding Disorders department is part of the company's Global Regulatory Affairs and situated in Søborg, Denmark. Our team contributes to the development of different products and projects within Rare Bleeding Disorders with a pipeline including various...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Regulatory Affairs Specialist for innovative development within Rare Disease Category: Reg Affairs & Safety Pharmacovigilance Location:Søborg, Capital Region of Denmark, DK Do you want to become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk's...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create AlertRegulatory Affairs Specialist for innovative development within Rare DiseaseCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you want to become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk's...
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