Global Product Approvals Manager
7 days ago
We are looking for a highly motivated and experienced Regulatory Affairs professional to join our team as a Senior Regulatory Affairs Specialist. In this role, you will be responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims, while supporting business objectives.
The ideal candidate will have relevant Bachelor's Degree or higher, 6+ years related regulatory experience, and expertise across a broad spectrum of Regulatory classifications. They will possess solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance and fluent proficiency in Danish & English.
Key responsibilities include:
- Providing regulatory input and technical guidance on local regulatory requirements
- Assessing the acceptability of quality, preclinical, and clinical documentation for submission filing
- Preparing and submitting regulatory submissions according to applicable regulatory requirements and guidelines
You will also maintain awareness of current regulations, anticipate implications and opportunities, and communicate changes to appropriate management and cross-functional experts.
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Global Product Security Manager
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Global Product Security Lead
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the JobThis role offers the opportunity to work with Contract Manufacturing Organizations (CMOs) located around the world. You will be responsible for ensuring QA oversight by activities such as visits at the CMO, compliance checks, approval of QMS documents, and release of Novo Nordisk insulin products to the market.You will work with a highly skilled...
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Senior Regulatory Affairs Specialist
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