Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The Regulatory Affairs Associate is responsible for providing support and guidance to investigators and others within the Cancer Consortium (Fred Hutch, UW, SCCA, Seattle Childrens) on regulatory issues and requirements related to the conduct of clinical trials and use of investigational products. The incumbent will support investigators and study teams in the preparation and review of FDA submissions and other regulatory documents, provide guidance to researchers on FDA regulations for clinical trials, assess protocols for adherence to regulatory requirements, and assist with FDA inspections. This position will represent the Regulatory Affairs Program to the Institution and Cancer Consortium by making presentations to staff, disseminating tools and information, and meeting with study teams and other departments on an ad hoc basis. The incumbent will work under the direction of the Sr. Regulatory Affairs Associate.
Provides regulatory consultation and support to investigators and staff throughout the lifecycle of a clinical trial
Reviews and edits complex submissions to FDA including IND/IDE applications, protocols, IND exemption requests, clinical hold responses, risk determination requests
Reviews and edits routine submissions to FDA including IND amendments, annual reports, and safety reports
Supports development and submission of expanded access IND applications
Reviews investigator-initiated, FDA-regulated protocols for regulatory compliance
Reviews research team documents and templates related to regulatory compliance, including Corrective and Preventive Action plans
Develops and maintains tools/templates for FDA submissions
Supports development of internal processes and standard operating procedures for the Consortium
Collaborates with CRS teams to support consistency in regulatory operations
Assists development of CRS training activities
Provides operational support for FDA inspections
Coordinates and supports external audits that include assessment of Institution- or Consortium-level resources and processes
Maintains current regulatory expertise through review of updated regulations and guidance, training sessions, conferences, and participation in professional associations
Exceptional writing and editing skills
Minimum of 2 years working in regulatory affairs with emphasis on INDs
Minimum of 2 years working with the conduct, oversight, assessment, or development of clinical research
Experience interpreting and applying regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice
Excellent communication and relationship-building skills across multiple levels of research teams and organizations
Experience preparing for audit or inspection activities
Experience drafting submissions and correspondence to FDA
Experience interacting with FDA representatives during inspections or meetings
Experience designing tools for the regulatory management of clinical trials
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at firstname.lastname@example.org or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.