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Regulatory Affairs Specialist II
Regulatory Affairs Specialist II-March 2024
Seattle
Mar 30, 2026
About Regulatory Affairs Specialist II

  ResponsibilitiesServes as a subject-matter expert in quality assurance and regulatory support for clinical research at Seattle Children's Research Institute. Guides and supports all clinical research team members in adhering to applicable federal regulations, state codes, institutional policies, and Institutional Review Board (IRB) oversight and reviews requirements when conducting research with human participants. Reviews, analyzes, and processes clinical research protocols, including associated documents, for submission to local and commercial IRBs. Assesses, analyzes, and implements regulatory requirements, policies, and guidance documents; creates and follows standard operating procedures (SOPs). Develops and delivers training and education to build and reinforce a culture of regulatory preparedness and quality assurance in clinical research practices, structures, and systems. Implements proven practices to ensure the quality of data collection and integrity, and documentation. Performs quality management activities in clinical research, ensuring research participants' safety, quality of study operations, and compliance with applicable research regulations and ICH/GCP guidelines. Coordinates, prepares, submits, and monitors regulatory documents and reports. Builds regulatory preparedness into research practices, structures, and systems by creating quality management plans. Operates on the team that oversees the electronic regulatory binder system.RequirementsRequired Education/Experience:Bachelor's Degree in biological sciences or health related field.Minimum of two (2) years experience in the pharmaceutical industry or clinical research organization in for-profit or academic setting.Required Credentials:N/A.Preferred:Master's Degree in biological sciences or health-related field.At least five (5) years experience in a regulatory role.Experience in drug and device approval process.RAPS certification or equivalent.#LI-DS1Min to Max Hourly Salary$36.75 - $55.12 /hrMin to Max Annual Salary$76,440.00 - $114,649.60 /yrSalary InformationThis compensation range was calculated based on full-time employment (2080 hours worked per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided.The union pay ranges can be found on the Seattle Children's website here: -Seattle Children's offers annual incentive pay based upon performance that is commensurate with the level of the position.Disclaimer for Out of State ApplicantsThis compensation range is specific to Seattle, positions located outside of Seattle may be compensated differently depending on various factors.Benefits InformationSeattle Children's offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more. here for more information.About UsHope. Care. Cure. These three simple words capture what we do at Seattle Children's - to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECUREAs one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine.Researchers work in close collaboratio

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