Manager, Quality Assurance and Regulatory Affairs

🔥 21 hours ago

🇺🇸 United States – Remote

💵 $112.1k - $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 1 day.
• Jobs at this company usually fill in 21 days.

Apply Now

Check your resume score

Customize resume + cover letter

Find Similar Remote Jobs

☆ Save☑️ Mark as applied❌ Hide

Report problem

Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Drive complex FDA regulatory submissions for biologic programs from Phase 1 through marketing applications (BLA/NDA) • Build and own quality systems • Translate executive strategy into compliant regulatory plans and submissions • Coordinate risk assessments balancing technical impact, patient safety, and regulatory compliance • Apply FDCA, PHS Act Section 351, 21 CFR, and FDA/ICH guidance to submissions • Guide cross-functional teams preparing pre-IND/INTERACT and FDA meeting requests • Author and review CMC, nonclinical, and clinical components of regulatory submissions • Support maintenance of INDs, including protocol amendments, safety reports, and change notifications • Prepare FDA meeting briefing materials, question strategies, and tracking minutes • Draft technical responses to FDA information requests and clinical holds • Represent Regulatory Affairs on program teams • Own CAPA, NCR, change control, and SOP management processes • Build and maintain agile quality systems • Support FDA and CDMO inspection readiness through mock inspections and document preparation • Manage and develop a team of quality and regulatory professionals as business needs require

🎯 Requirements

• B.S., M.S., or equivalent in Life Sciences, Pharmacy, Chemistry, Biochemistry, or Engineering; experience may substitute for education • 5-8 years of biotech or pharma industry experience in regulatory affairs, including Phase 1 IND through marketing application • Hands-on experience with eCTD and FDA ESG submissions • Working knowledge of FDA biologics regulations, including 21 CFR Parts 11, 50, 56, 58, 210/211, 312, 600-610, and ICH guidelines • Direct experience managing CAPA, NCR, and change control in an electronic QMS • Experience with CBER- or CDER-regulated biologics, including monoclonal antibodies, recombinant proteins, or cell/gene therapy • CDMO oversight and phase-appropriate GMP experience • Capable of operating independently and building structure where it is missing • Strong scientific writing and risk assessment skills, relying on evidence and data to make decisions • Clear, proactive communication and ability to adapt quickly to shifting priorities • RAC certification or ASQ CQA/CQE is a plus

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents • Free testing for employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Employee referral program • Equal Opportunity Employer and inclusive workplace

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume