Manager Quality Assurance and Regulatory Affairs

Natera; United States; Remote; USD 112,000 - 150,000; Full time

Benefits offered by this job

Competitive Benefits

401(k) matching

Job summary

Natera in the United States is seeking a Manager of Regulatory Affairs and Quality Assurance (Biologics) to drive complex FDA submissions for biologic programs from Phase 1 to BLA/NDA. You will build and own quality systems, guide cross-functional teams, and ensure rapid, compliant approvals while balancing patient safety and regulatory requirements.

The role requires hands-on eCTD experience, strong scientific writing, and leadership to support IND maintenance and regulatory inspections.

Qualifications

• B.S., M.S., or equivalent in Life Sciences, Pharmacy, Chemistry, Biochemistry, or Engineering (experience may substitute for education).
• 5-8 years biotech/pharma regulatory affairs experience.
• Hands-on eCTD and FDA ESG submissions experience.
• Knowledge of FDA biologics regulations (21 CFR Parts 11, 50, 56, 58, 210/211, 312, 600-610) and ICH guidelines.
• Experience managing CAPA, NCR, and change control in an electronic QMS.

Responsibilities

• Turn strategy and product priorities into regulatory plans and submissions.
• Apply FDA and ICH guidelines to build compliant submissions.
• Lead cross-functional teams for pre-IND/INTERACT and FDA meeting requests.
• Author/review modules of regulatory submissions (CMC, nonclinical, clinical).
• Support IND maintenance with amendments, safety reports, and change notifications.
• Prepare briefing materials and FDA response strategies.
• Represent RA in program teams to meet regulatory requirements with minimal burden.
• Own core quality-system processes (CAPA, NCR, change control, SOPs).
• Build agile quality systems to enable timely product delivery.
• Support inspection readiness (PAI/PLI, BIMO) through mock inspections.

Skills

Regulatory strategy

FDA/regulatory submissions

Biologics knowledge

Technical writing

CAPA/NCR/change control

eCTD submissions

QMS implementation

Risk assessment

Cross-functional leadership

Education

Bachelor's or Master's in Life Sciences/Engineering

Tools

eCTD software

Job description

Manager Quality Assurance and Regulatory Affairs

US Remote

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 amendments, safety reports, and change notifications.

Prepare briefing materials, question strategies, and tracking minutes for FDA meetings.

Draft technical responses to FDA information requests and clinical holds.

Represent Regulatory Affairs on program teams to ensure deliverables meet regulatory requirements with the least-burdensome approaches.

Own core quality system processes, including CAPA, nonconformance reports (NCRs), change control, and SOP management.

Build and maintain agile quality systems that ensure compliance without slowing down our ability to deliver critical products.

Support FDA and CDMO inspection readiness (PAI/PLI, BIMO) through mock inspections and document preparation.

Manage and develop a team of quality and regulatory professionals as business needs require.

QUALIFICATIONS:

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. Biologics experience preferred.

Hands-on experience with eCTD and FDA ESG submissions.

Working knowledge of FDA biologics regulations (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.

KNOWLEDGE, SKILLS, AND ABILITIES:

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 communicator who adapts quickly to shifting priorities .

Experience with CBER- or CDER-regulated biologics (monoclonal antibodies, recombinant proteins, cell/gene therapy).

RAC certification or ASQ CQA/CQE is a plus.

CDMO oversight and phase-appropriate GMP experience.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Remote USA

$112,100 - $150,000 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

If you are based in California, we encourage you to read this important information for California residents.

Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.