Regulatory Affairs Specialist

Job Summary

To support regulatory operations, the full-time Regulatory Affairs Specialist will manage document submissions, maintain regulatory tracking systems, and ensure compliance with applicable regulations while working remotely.

Key responsibilities

• Maintaining regulatory tracking and archiving of submissions in document management systems
• Publishing regulatory documents and submissions according to ICH eCTD format and client style guides
• Preparing and compiling documents for submission to regulatory health authorities, performing quality control checks for compliance

Required qualifications

• College graduate in a scientific, medical, clinical discipline, or related field; master's preferred
• Minimum of 3 years' experience in Regulatory Affairs, Regulatory Operations, or Publishing
• Proficiency with MS Word Formatting, Adobe, and other MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements