Regulatory Quality Specialist

Professional Recruiter | Insight Global | Pennsylvania State University Alumni

Regulatory Site Quality Specialist

A large CPG client of ours is looking for a regulatory site quality specialist to help with their products OTC drug listing portfolio. This role is responsible for managing the drug listing process, including the listing and delisting of products (skincare, cosmetics). The position supports regulatory tasks and regulatory operations as needed, while collaborating with cross‑functional teams on the initiation, review, and approval of change requests, deviations, and CAPAs.

Key responsibilities include reviewing and approving incoming raw material documentation, LIMS specifications, and Certificates of Analysis, as well as GMP batch records, packaging protocols, clinical labeling records, and analytical laboratory documentation such as test methods, protocols, and reports. The role also involves participating in internal audits as a scribe and document reviewer, providing GMP consultation to project teams and departments, and serving as a backup for the QA Manager.

• BS degree in science or engineering
• 5 years' experience in Regulatory, Quality, R&D or Analytical in a GMP facility
• Experience and understanding of FDA OTC Drug Listing Process
• Experience and understanding GMP Procedures
• Experience with SOPs, deviations, change controls, CAPAs
• Detail Oriented, Organized
• OTC Drug or Cosmetics Experience

• LIMS experience
• Cosmetics or skincare experience