Regulatory Affairs Associate/Senior Regulatory Affairs Associate

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Regulatory Affairs Associate (RAA)/Regulatory Affairs Associate Sr. is responsible for supporting investigators and staff within the Infectious Disease Sciences (IDS) Program in the Vaccine and Infectious Disease Division on regulatory issues and requirements through the full cycle of clinical trials and human subjects research. The RAA oversees communications with industry sponsors and the Fred Hutch IRB, prepares regulatory documentation, coordinates regulatory submissions and monitoring, maintains regulatory files, and facilitates regulatory oversight for all related studies. This role interacts extensively with the Institutional Review Office (IRO), principal investigators, study teams, internal departments, and external organizations and agencies. The incumbent is expected to work independently within established regulations and guidelines, demonstrating initiative, sound judgment, and the ability to provide regulatory guidance and assist with resolving compliance issues. The position reports to the Senior Project Manager in the IDS Program.

This role will have the opportunity to work partially at our campus and remotely.

Responsibilities

Study Start-Up, Maintenance & Close-Out:

• Prepare and submit regulatory applications to the IRB and other governing bodies--including initial submissions, renewals, amendments, modifications, consent forms, safety reports, study updates, and IND-related documents--ensuring timely completion and compliance with GCP, institutional policies, and federal regulations.
• Determine the appropriate IRB of record for new studies and ensure all required IRB-specific documents and submission materials are collected and prepared accordingly.
• Draft, review, track, and maintain all regulatory correspondence and documentation required by the IRB, the FDA, sponsors, CROs, and oversight committees.
• Maintain compliance with all regulatory bodies by submitting required documents and ensuring accurate version control.
• Prepare and present materials for monitoring visits; serve as the primary point of contact and independently resolve regulatory findings.
• Maintain regulatory binders and electronic tracking systems (SharePoint, OneDrive, OnCore, CTMS, shared drives).
• Coordinate and manage regulatory documents from participating sites when serving as the IRB of record and/or coordinating center.
• Report noncompliance and unanticipated problems to the IRB in accordance with reporting guidelines.
• Conduct study closeout activities and archive all regulatory records in alignment with guidelines and SOPs.
• Collaborate with PIs, study teams, and finance teams on regulatory components of funding proposals and annual progress reports.
• Process external IND safety reports, document PI review, and submit reports to the IRB as appropriate.

Regulatory Consultation & Support:

• Serve as a primary regulatory resource for PIs, sponsor-investigators, sponsors, and study teams, providing guidance on approvals, regulatory status, and the informed consent process.
• Provide regulatory consultation throughout the lifecycle of clinical trials and human subjects' research.
• Advise investigators and clinical research staff on regulatory requirements, processes, guidelines, and best practices.
• Participate in discussions regarding regulatory interpretation with investigators, research teams, and finance groups.
• Facilitate, submit, and track protocols through required approval pathways (e.g., FDA, IRBs).
• Ensure participating sites meet all regulatory requirements for site activation.
• Provide regulatory oversight for safety reporting across studies.
• Serve as an internal resource for resolving complex regulatory questions and issues.
• Assist with regulatory tracking, archiving systems, and overall project coordination to ensure milestones and deadlines are met.
• Support coordination of clinical documentation including IRB/IBC approvals, safety reports, deviations, lab certifications, staff training, and compliance records.
• Liaise with internal regulatory bodies (IRB, IRO, Clinical Research Support, Regulatory Affairs), external agencies (FDA, OHRP,), and external IRBs (e.g., Advarra, WCG).
• Review consent forms and regulatory documents for participating sites.
• Support FDA communications and inspections.

Compliance/Quality Assurance/Policies:

• Monitor, interpret, and communicate changes in regulatory legislation and institutional policies to relevant faculty and staff.
• Apply sound judgment in interpreting and implementing federal and local regulations related to clinical research.
• Identify regulatory risks and recommend mitigation strategies.
• Ensure proper management, version control, retention, archiving, and off-site storage of regulatory files and master files.
• Perform internal audits and quality assurance reviews to ensure regulatory accuracy and adherence to standards.
• Stay current on evolving regulatory requirements and disseminate relevant updates to study teams.
• Partner with institution-wide regulatory support programs and leadership to design, develop, and implement SOPs consistent with FDA/ICH regulations.
• Identify gaps and implement revisions to policies and procedures related to regulatory operations.

Other Duties:

• Perform additional tasks as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

Regulatory Affairs Associate:

• Bachelor's degree or equivalent combination of education and experience.
• Minimum 2 years of regulatory/IRB related experience in a clinical research environment.

Regulatory Affairs Associate Sr:

• Bachelor's degree or equivalent experience (in lieu of education)
• Minimum 5 years of regulatory/IRB related experience in a clinical research environment.

PREFERRED QUALIFICATIONS:

• Clinical research related certification preferred.
• Prior experience working with E-Binders (e.g., Florence)
• Previous experience with IND submissions to the FDA.
• Previous experience with IACUC support/submissions.
• Previous experience preparing and reviewing Human Subjects Research applications, and Non-Human Subject Determinations and IRB exemptions.
• Experience communicating with an IRB, and as needed communications with FDA and preparing for FDA inspections.
• Assessing risk in the conduct of clinical research
• Interpreting federal regulations and guidelines
• Ability to work with all levels of research teams
• Excellent interpersonal skills and attention to detail.
• Strong written and oral communication skills
• Familiarity with process improvement principles
• Knowledge of regulations and guidelines that govern clinical research and human subjects research compliance, including, but not limited to FDA and Good Clinical Practice regulations.
• Other Required Experience for Regulatory Affairs Associate Sr. (in addition to above experience at Regulatory Affairs Associate level):
• Extensive and current working knowledge of FDA regulations, GCP, and International Conference on Harmonization guidelines.
• Previous experience with IND submissions and study management for studies associated requiring Federal Drug Agency authorization and review.
• Honed knowledge of clinical trial safety issues.
• Professional Society Certification (RAC) and background in pharmaceutical regulatory affairs or law strongly desired.

Regulatory Affairs Associate: The annual base salary range for this position is from $80,172 to $114,940, and pay offered will be based on experience and qualifications.

Regulatory Affairs Associate Sr: The annual base salary range for this position is from $97,822 to $146,681, and pay offered will be based on experience and qualifications.