Regulatory Compliance Analyst

Apply knowledge of U.S. dietary supplement regulations, including DSHEA and FDA cGMP requirements (21 CFR Part 111), to ensure day to day manufacturing and packaging activities are conducted in compliance with regulatory expectations.Carefully review batch production and packaging records to confirm that all steps were completed correctly, documented properly, and meet established quality and GMP standards before product release.Evaluate incoming raw materials, packaging components, and finished products by examining Certificates of Analysis, supplier documents, and internal specifications to ensure they meet required quality and regulatory criteria.Review product labels and packaging content, including supplement facts panels, ingredient declarations, allergen statements, and marketing claims, to ensure alignment with guidelines.Work alongside R&D and quality teams to support new product development or reformulation by assessing ingredient safety, usage levels, and allowable structure/function claims from a regulatory standpoint. Maintain and organize regulatory and quality documentation such as SOPs, master manufacturing records, specifications, and compliance logs, ensure documents are accurate, up to date, and audit ready.Stay informed on changes in dietary supplement regulations and industry practices, and communicate relevant updates to internal teams to support ongoing compliance.Assist in preparing for internal audits and regulatory inspections by gathering required documentation, supporting inspection activities, and helping address any observations or findings.Investigate quality issues such as deviations, out-of-specification results, or non-conformances, and contribute to the development and follow-up of corrective and preventive actions.Perform routine checks on the production and packaging floor, including line clearance and in-process inspections, to verify that operations are being carried out according to approved procedures.Coordinate with cross-functional teams such as Quality Assurance, Production, Packaging, and Supply Chain to ensure compliance is maintained throughout the entire product lifecycle.Support supplier qualification activities by reviewing vendor documentation, GMP certifications, audit reports, and quality agreements to ensure third-party compliance.Assist in handling product complaints and adverse event reports by ensuring proper documentation, timely investigation, and appropriate regulatory follow-up when required.Bachelor's Degree is required  in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Regulatory Affairs