Regulatory Affairs Specialist II

Seattle Children's; Seattle (WA); On-site; USD 83,000 - 124,000; Full time

Benefits offered by this job

Medical, dental, and vision plans

403(b) retirement plan

Paid time off

Job summary

Seattle Children’s Research Institute seeks a subject-matter expert in quality assurance and regulatory support for clinical research. You will guide teams to comply with federal regulations, state codes, institutional policies, and IRB oversight when working with human participants.

You will review protocols for IRB submission, implement SOPs, deliver training, and ensure data integrity and participant safety across study operations in line with ICH/GCP guidelines.

Qualifications

• Bachelor’s degree in biological sciences or health-related field required.
• Minimum of two years of experience in the pharmaceutical industry or a clinical research organization (for-profit or academic).
• Experience with regulatory submissions and IRB processes preferred.

Responsibilities

• Reviews, analyzes, and processes clinical research protocols for submission to IRBs.
• Assesses and implements regulatory requirements, policies, and guidance documents; develops SOPs.
• Develops and delivers training to promote regulatory preparedness and quality assurance in clinical research practices.

Skills

Quality assurance

Regulatory compliance

Clinical research

IRB oversight

SOP development

Training delivery

GCP/ICH knowledge

Regulatory submissions

Education

Bachelor’s degree in biological sciences or health-related field

Job description

Serves 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 review 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. Implement 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.

Required Education and 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.

Compensation Range

$82,736.00 - $124,104.00 per year

Salary Information

This 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.

Disclaimer for Out of State Applicants

This compensation range is specific to Seattle, positions located outside of Seattle may be compensated differently depending on various factors .

Benefits Information

Seattle Children’s offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more. Additional details on our benefits can be found on our website www.seattlechildrens.org/careers/benefits .

About Us

Hope. 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? #HOPECARECURE

Our founding promise to the community is as valid today as it was over a century ago: we will care for all children in our region, regardless of the families’ ability to pay. Together, we deliver superior patient care, advance new discoveries and treatments through pediatric research, and serve as the pediatric and adolescent, academic medical center for Washington, Alaska, Montana and Idaho – the largest region of any children’s hospital in the country.

U.S. News & World Report consistently ranks Seattle Children’s among the nation’s best children’s hospitals. For more than a decade, Seattle Children’s has been nationally recognized in key specialty areas. We are honored to be one of the nation’s very best places to care for children and the top-ranked pediatric hospital in Washington and the Pacific Northwest.

As a Magnet designated institution, we recognize the importance of hiring and developing great talent to provide best-in-class care to the patients and families we serve. Our organizational DNA takes form in our core values: Compassion, Excellence, Integrity, Collaboration, Equity and Innovation. Whether it’s delivering frontline care to our patients in a kind and caring manner, practicing the highest standards of quality and safety, or being relentlessly curious as we work towards eradicating childhood diseases, these values are the fabric of our culture and community. The future starts here.

Our Commitment

Seattle Children’s welcomes people of all experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our patients and families. Our organization recruits, employs, trains, compensates, and promotes based on merit without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

The people who work at Seattle Children’s are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves.

Seattle Children’s is proud to be an Equal Opportunity Workplace and Affirmitive Action Employer.