Regulatory Affairs Manager
Amgen(2 months ago)
About this role
A Regulatory Affairs Manager at Amgen supports regional regulatory activities to ensure compliance, licensing, and regulatory strategy across the product lifecycle for investigational and marketed medicinal products. The role sits within the European General Medicine Regulatory team and contributes to regional regulatory planning across multiple therapeutic areas.
Required Skills
- Regulatory Submissions
- Regulatory Strategy
- Regulatory Research
- Legislation Knowledge
- Clinical Trials
- Label Negotiation
- Communication
- Scientific Writing
- Risk Assessment
- Project Management
Qualifications
- Scientific Degree
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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