Senior Manager, Regulatory Affairs
Cepheid(4 months ago)
About this role
A Senior Manager, Regulatory Affairs at Leica Biosystems focuses on global regulatory activities for high-complexity diagnostics in clinical oncology, including IVDs, companion diagnostics, and digital pathology. The role is part of the Global Regulatory Affairs Team based in Newcastle, UK and supports the commercialization of innovative diagnostic technologies across international markets.
Required Skills
- Regulatory Strategy
- Global Submissions
- Team Leadership
- Cross-Functional Collaboration
- Clinical Trials
- Agency Negotiation
- Product Commercialization
- Regulatory Compliance
- Risk Analysis
Qualifications
- Bachelor’s Degree in Science or Engineering
- Master’s Degree in Science or Engineering
- PhD in Science or Engineering
About Cepheid
cepheid.comCepheid is delivering a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.
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