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Manager Quality Assurance and Regulatory Affairs
Natera
2 days ago
Full-time
Remote
Worldwide
Remote Healthcare
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POSITION SUMMARY: The Manager, Regulatory Affairs and Quality Assurance (Biologics) drives complex FDA regulatory submissions for biologic programs, from Phase 1 through marketing applications (BLA/NDA). At Natera, we move fast because there is a patient waiting for every test and treatment. In this role, you will build and own quality systems, translate executive strategy into compliant submissions, and provide regulatory guidance to ensure rapid product approvals. You will coordinate risk assessments balancing technical impact, patient safety, and regulatory compliance.
PRIMARY RESPONSIBILITIES:
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