Regulatory Affairs Specialist II

Seattle Children’s Research Institute seeks a Regulatory Affairs Specialist II to provide quality assurance and regulatory support for clinical research. The role guides research teams on regulatory and IRB requirements, reviews and processes protocols, and implements regulatory practices, training, and quality management activities.

Responsibilities

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

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

At least five (5) years experience in a regulatory role.

Biological Sciences

Health-Related Field

Regulatory Affairs

Drug Approval Process

Medical Device Approval

RAPS Certification

Benefits

Medical, dental, and vision plans

403(b)

Life insurance

Paid time off

Tuition reimbursement

Hybrid remote work (80% remote)

Company

Pediatric hospital and research institute providing care

Seattle, Washington, USA

https://www.seattlechildrens.org/

Founded in 1907

10001+ employees

Qualifications

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

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

Minimum of two (2) years experience in the pharmaceutical industry or clinical research organization in for-profit or academic setting.

Required skills

Clinical Research, Pharmaceutical Industry, Regulatory Affairs, Drug and Device Approval Processes, RAPS Certification

Preferred skills

At least five (5) years experience in a regulatory role, Experience in drug and device approval process, RAPS certification or equivalent

Experience

2+ years