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Remote, Oregon, United States
Remote only
Not Available
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.
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!
For more information, visit www.natera.com.
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.
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
