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Position Summary:
- Drives complex FDA regulatory submissions for biologic programs from Phase 1 through marketing applications.
- Builds and owns quality systems, translating executive strategy into compliant submissions.
- Coordinates risk assessments balancing technical impact, patient safety, and regulatory compliance.
Primary Responsibilities:
- Turn executive strategy into actionable regulatory plans and submissions.
- Guide cross-functional teams in preparation for FDA meeting requests.
- Own core quality system processes including CAPA, NCR, change control, and SOP management.
Qualifications and Skills:
- 5-8 years of biotech or pharma industry experience in regulatory affairs.
- Hands-on experience with eCTD and FDA ESG submissions.
- Direct experience managing CAPA, NCR, and change control in an electronic QMS.
Natera
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.