New · posted Nov 14
Natera · Biotechnology
Manager, Quality Assurance and Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Manager
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.
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 you need
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
Skills named in this posting
What you'll do
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.
Pay
$112,100 – $150,000 a year
Employer providedCompetitive 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!
For more information, visit www.natera.com.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-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.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
Equal opportunity, accessibility and legal noticesNatera's statements, word for word
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.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
Job intelligence
The context around this role
Live data · November 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in the US22 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $112,100 | — | $150,000 |
| All US (middle half) | $147,125 | $161,250 | $171,000 |
This role: Natera's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, November 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 165 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Natera's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Regulatory submissions7
- GMP and compliance6
- Quality systems and risk5
- Documentation and SOPs4
- Lab testing and methods3
- Investigations and CAPA2
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Affairs work in biotechnology, led by the seven this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLANamed in the posting
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissionsNamed in the posting
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissionsNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labsNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDA21 CFR Part 1271(official source, opens in a new tab)Human cells, tissues, and cellular and tissue-based products
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Natera on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 3
- Locations
By discipline
- Quality2 40%
- Clinical2 40%
- Regulatory1 20%
By level
- Director2 40%
- Manager2 40%
- Associate & Specialist1 20%
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Manager, Quality Assurance and Regulatory Affairs at Natera
Open until filled. $112K–$150K a year, employer provided.