Regulatory Affairs Analyst

Coordinate, prepare, and technically review data or reports for regulatory submissions for projects. Coordinate with manager to develop and implement regulatory plans to ensure full compliance with regulatory agencies (Environmental Protection agency, Occupational Safety and Health Administration FDA, and others) and with internal standards. Work in compliance with Code of Conduct and regulatory standards and address regulatory related questions and inquiries promptly. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. Prepare and maintain regulatory documents in eCTD format for reference and easy retrieval and update the standards in accordance with current FDA regulations, checking for expired/outdated products. Prepare ongoing regulatory agency fees (PDUFA, GDUFA), filings and amendments and ensure compliance by preparing or directing the preparation of additional information or responses as requested by regulatory agencies including health authority requirements. Review business documents and SOPs for accuracy. Degree requirements: Masteru2019s degree in Regulatory Affairs, Pharmaceutics, Biomedical Sciences, or related field of study with 1 year job related experience (Any title). Special Requirements:Experience in: Active Pharmaceutical Ingredients analysis; analytical chemistry techniques; testing (wet lab analysis, dissolution); pH and titration techniques; USP Reference standards; and work with: cGMP, GLP, and Empower software. Relocation and travel to various unanticipated locations within USA possible.

Created: 2026-04-16