Regulatory Affairs Specialist

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