Manager Quality Assurance and Regulatory Affairs

Natera·US Remote·Remote·Posted 13 November 2026

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About the role

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: Turn executive strategy, development priorities, and target product profiles into actionable regulatory plans and submissions. Apply in-depth knowledge of FDCA, PHS Act Section 351, 21 CFR, and FDA/ICH guidance to build submissions that meet current agency expectations. Guide cross-functional teams in preparation for pre-IND/INTERACT and FDA meeting requests (Type A/B/C/D, pre-BLA/NDA). Author and review CMC (Module 3), nonclinical (Modules 2.4/2.6, 4), or clinical (Modules 2.5/2.7, 5) components of regulatory submissions. Support RA leadership in maintaining INDs, including protocol…

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