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Clinical and Regulatory Affairs Specialist

Orlance, Inc. • Spokane, WA, US • published 2026-11-13 07:00:59.144628

Description

**Overview** As a Clinical and Regulatory Affairs Specialist, you’ll connect clinical research, medical affairs, and regulatory requirements to support safe, compliant product development. You’ll turn clinical evidence and health regulation policy into clear documentation and practical guidance for cross\-functional teams. Orlance develops innovative vaccines and immunotherapies for multiple indications. Compensation based upon overall and directly relevant experience, within range shown. \*\*POSITION REQUIRES EMPLOYEE TO RESIDE IN SPOKANE COUNTY, WASHINGTON DUE TO FUNDING SOURCE. NO EXCEPTIONS\*\* Your impact: Accurate research and regulatory submissions help teams make informed development decisions and support patient safety. **Duties** * Establish plans for future clinical research activities, including data collection, analysis, and interpretation for clinical trials and clinical development. * Prepare and review regulatory submissions, medical writing, and technical writing for researchers in line with FDA regulations and pharmaceutical regulatory compliance. * Apply Good Clinical Practice (GCP), healthcare compliance, and biomedical regulatory compliance requirements to rese...

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