Regulatory Quality Specialist

Insight Global; Florham Park (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A prominent staffing firm is seeking a Regulatory Site Quality Specialist in Florham Park, NJ. The role involves managing the OTC drug listing portfolio, participating in regulatory tasks, and collaborating across teams. Key qualifications include a BS degree in science or engineering and at least 5 years of experience in a GMP environment. Candidates should possess a strong understanding of FDA procedures and be detail-oriented. This is a unique opportunity to work within a dynamic and challenging sector.

Qualifications

• 5 years' experience in Regulatory, Quality, R&D or Analytical in a GMP facility.
• Experience with FDA OTC Drug Listing Process.
• Knowledge of GMP Procedures, SOPs, deviations, change controls, CAPAs.

Responsibilities

• Manage drug listing process including listing and delisting of products.
• Collaborate with cross-functional teams on change requests, deviations, and CAPAs.
• Review and approve incoming raw material documentation, LIMS specifications, and Certificates of Analysis.

Skills

Attention to Detail

Organizational Skills

OTC Drug or Cosmetics Experience

Education

BS degree in science or engineering

Tools

LIMS

Job description

Professional Recruiter | Insight Global | Pennsylvania State University Alumni

Regulatory Site Quality Specialist

JOB DESCRIPTION

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.

REQUIRED SKILLS AND EXPERIENCE

• 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

NICE TO HAVE SKILLS AND EXPERIENCE

• LIMS experience
• Cosmetics or skincare experience