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Fda Biologist Jobs in Arizona (NOW HIRING)

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Administers prescribed intravenous and subcutaneous medications and biologics, adhering to prescriber order and applicable FDA dosing parameters * Evaluates the effectiveness of the health care ...

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Showing results 1-20

Fda Biologist information

See Arizona salary details

$34.5K

$83.3K

$128.6K

How much do fda biologist jobs pay per year?

As of Aug 10, 2026, the average yearly pay for fda biologist in Arizona is $83,314.00, according to ZipRecruiter salary data. Most workers in this role earn between $55,400.00 and $112,800.00 per year, depending on experience, location, and employer.

What are the typical daily responsibilities of an FDA biologist?

An FDA Biologist’s daily tasks often include reviewing scientific data, conducting laboratory experiments, and preparing reports on biological product submissions. You may assess the safety and efficacy of products such as vaccines or medical devices, ensuring compliance with regulatory standards. Collaboration with interdisciplinary teams—including chemists, statisticians, and regulatory affairs specialists—is common to address scientific questions and support regulatory decision-making. The role also involves staying updated on scientific advancements and regulatory changes relevant to the field. This dynamic environment provides opportunities to contribute to public health while developing specialized expertise.

What are the key skills and qualifications needed to thrive in the FDA biologist position, and why are they important?

To thrive as an FDA Biologist, you need a degree in biology or a related scientific field, strong analytical and laboratory skills, and a solid understanding of regulatory requirements. Familiarity with laboratory instruments, scientific data analysis tools, and regulatory databases such as GLP (Good Laboratory Practice) systems is important. Attention to detail, effective communication, and strong problem-solving abilities are valuable soft skills in this role. These competencies are crucial for accurately evaluating biological data, ensuring regulatory compliance, and collaborating effectively within multidisciplinary teams at the FDA.

What is an FDA biologist?

An FDA Biologist is a scientist who evaluates biological products, research data, and laboratory studies to ensure public health and safety. They work on regulatory reviews, inspections, and policy development related to vaccines, gene therapy, blood products, and other biologics. Their role helps ensure compliance with federal regulations and supports scientific advancements in healthcare.

What job categories do people searching Fda Biologist jobs in Arizona look for? The top searched job categories for Fda Biologist jobs in Arizona are:
Infographic showing various Fda Biologist job openings in Arizona as of August 2026, with employment types broken down into 58% Full Time, and 42% Contract. Highlights an 100% In-person job distribution, with an average salary of $83,314 per year, or $40.1 per hour.

Manager Sponsor Regulatory Affairs & Institutional Trial Compliance

Honorhealth

Scottsdale, AZ • On-site

Full-time

Posted 22 days ago


HonorHealth rating

7.7

Company rating: 7.7 out of 10

Based on 209 frontline employees who took The Breakroom Quiz

158th of 887 rated healthcare providers


Job description

Primary City/State:

Shea Medical Office Building - 10197 N 92nd St Scottsdale, AZ 85258

Category:

Research Operations

Shift:

Day

Department:

HRI-Translational Research

Monday-Friday

Great care starts with great people. (Like you.)

At HonorHealth, you'll find something special. From humble beginnings in 1927 to one of Arizona's largest nonprofit healthcare systems, our culture is built on warmth and neighborly kindness. Behind every smile is a highly skilled professional with deep expertise and an unwavering dedication to what matters most - caring for the health and well-being of people and communities across the greater Phoenix area.

Responsibilities:

JOB SUMMARY

Provides strategic and operational leadership for the Office of Regulatory Affairs and Research Oversight in the Division of Institutional Research, responsible for sponsor regulatory oversight of institutionally sponsored clinical trials conducted throughout the health system. Ensures full compliance with FDA regulations, ICH Good Clinical Practice, federal requirements, state requirements, and institutional policies governing sponsor responsibilities. Leads regulatory infrastructure that supports trial startup, conduct, safety oversight, multi-site expansion, reporting obligations, quality systems, and inspection readiness. Partners across the enterprise to create an efficient, scalable, and high performing sponsored trials program.

ESSENTIAL FUNCTIONS
  • Sponsor Regulatory Strategy and Agency Compliance:Lead implementation of regulatory strategy for institutionally sponsored clinical trials, including drug, device, biologic, behavioral, and observational studiesDetermine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated statusOversee preparation and submission of INDs, IDEs, amendments, annual reports, safety reports, protocol changes, and closeout filings as requiredServe as primary institutional contact with FDA and other regulatory agencies regarding sponsor mattersMonitor changes in regulations, guidance, and enforcement trends, then implement required operational changesEnsure fulfillment of sponsor commitments, reporting deadlines, and regulatory obligationsProvides guidance to leadership on regulatory risk, escalation items, and remediation strategy.
  • Trial Startup, Lifecycle Management, and Sponsor Oversight:Lead sponsor regulatory and compliance startup processes from concept approval through study activationOversee regulatory readiness for protocol finalization, informed consent documents, investigator qualifications, site documents, and essential regulatory recordsApprove activation of internal and external participating sites once sponsor requirements are metDirect amendment implementation processes across all participating sitesOversee study closeout, final reporting, archival readiness, and record retention requirementsSupport expansion of institutional trials into multi-site networks and affiliated partnersEnsure delegation of sponsor responsibilities to CROs, monitors, vendors, or external partners is documented and controlledEnsure trial institutional reporting requirements such as to CT.Gov, registration and reporting are completed within the institutional regulatory guidelines.
  • Safety Oversight, Quality Systems, and Inspection Readiness:Establish sponsor systems for adverse event review, serious adverse event reporting, unanticipated problem management, and safety signal escalationCoordinate oversight bodies such as DSMBs, independent medical monitors, adjudication committees, and safety review committees when requiredMaintain sponsor Trial Master File standards, completeness, version control, and inspection readinessEnsure regulatory data fields are complete in electronic research support systemPartner with Data Manager to conduct IND/IDE tracking and create reporting dashboardsPartner with Quality Assurance, Compliance, IRB, and operational leaders on audits, monitoring findings, CAPAs, and corrective actionsLead internal audit readiness program and conduct mock FDA inspectionsLead preparation for FDA inspections, sponsor audits, and external regulatory reviewsIdentify systemic compliance risks and implement preventive controls
  • Governance, Policy, Training, and Enterprise Collaboration:Develop and maintain sponsor SOPs, work instructions, templates, governance charters, and operational standardsCreate standardized pathways for investigator initiated and institutionally sponsored trialsEducate investigators, research staff, executives, and operational departments on sponsor obligations and regulatory expectationsPartner with IRB, legal, contracting, finance, pharmacy, laboratory, privacy, data governance, and revenue cycle teams to align study operationsAdvise investigators on regulatory and institutional compliance documentation needs during protocol development to improve feasibility and regulatory successPromote a culture of accountability, service, compliance, and operational excellence across the research enterprise
  • Leadership, Talent Management, and Financial Stewardship:Build, lead, mentor, and evaluate a high performing sponsor regulatory affairs teamEstablish staffing models aligned with institutional trial volume and complexityWork with project coordinators to set performance metrics for study startup timelines, as it pertains to regulatory and compliance documentationDevelop and manage departmental operating and capital budgetsIdentify efficiencies, automation opportunities, and scalable systems that improve productivity and reduce cycle timesProvide regular dashboards and strategic updates to executive leadershipSupport long term growth of the institutional sponsored trial portfolio

EDUCATION
  • Bachelors Required
  • Masters in health administration, public health, regulatory science, business, nursing, pharmacy, law, or related field Preferred

EXPERIENCE
  • 6 years, of progressive clinical research experience Required
  • 3 years, of leadership experience in regulatory affairs, sponsor operations, quality systems, or clinical trial administration Required
  • 3 years, of experience with IND, IDE, FDA submissions, or sponsor held trials Preferred
  • 3 years, of experience building teams, systems, and operational infrastructure Preferred

LICENSE AND CERTIFICATIONS
  • Society of Clinical Research Associates CCRP Preferred
  • Association of Clinical Research Professionals CCRC Preferred
  • Regulatory Affairs Professionals Society RAC Preferred
  • PMP Preferred

We're all in for your career.


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About HonorHealth

Sourced by ZipRecruiter

HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation, and community services with approximately 13,100 team members, 3,500 affiliated providers and nearly 700 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth's mission is to improve the health and well-being of those we serve.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Scottsdale, AZ, US

Year founded

2014