Regulatory Affairs Associate Job at Insight Global, Florham Park, NJ

dnUrL3NjVmlzMFpTMFhENGlEQ25CK25x
  • Insight Global
  • Florham Park, NJ

Job Description

Regulatory Site Quality Specialist

Location: hybrid (Florham Park, NJ

Type: Contract | Full-Time

Industry: Large Consumer Packaged Goods (CPG) Company

Job Overview

We are seeking a Regulatory Site Quality Specialist to support a leading CPG company’s OTC drug listing portfolio. This role will manage the drug listing process for skincare and cosmetic products, ensuring compliance with FDA regulations and GMP standards. You will collaborate with cross-functional teams to review and approve change requests, deviations, and CAPAs, while providing GMP consultation and supporting regulatory operations.

Key Responsibilities

  • Manage OTC drug listing and delisting processes for skincare and cosmetic products.
  • Review and approve raw material documentation, LIMS specifications, Certificates of Analysis, GMP batch records, packaging protocols, and clinical labeling records.
  • Support analytical documentation including test methods, protocols, and reports.
  • Participate in internal audits as a scribe and document reviewer.
  • Provide GMP consultation to project teams and departments.
  • Serve as backup for QA Manager as needed.

Required Skills & Experience

  • BS degree in Science or Engineering.
  • 5+ years’ experience in Regulatory, Quality, R&D, or Analytical roles within a GMP facility.
  • Strong understanding of FDA OTC Drug Listing Process and GMP procedures.
  • Experience with SOPs, deviations, change controls, and CAPAs.
  • Detail-oriented and highly organized.
  • OTC drug or cosmetics experience.

Nice to Have

  • LIMS experience.
  • Cosmetics or skincare experience.

Job Tags

Full time, Contract work,

Similar Jobs

24 Seven Talent

Luxury Stock Associate Job at 24 Seven Talent

 ...Job Title: Luxury Stock Associate Location: Wall Street, New York, NY Schedule: Full-Time Compensation: $21-$24/hr Start Date: ASAP Overview: We are seeking a detail-oriented and polished Luxury Stock Associate to support a high-end, multi-brand... 

Tandym Group

Psychiatric Nurse (RN) - Nights Job at Tandym Group

 ...A social services organization in New York City is currently seeking a licensed Registered Nurse (RN) to join their Psychiatric team in Brooklyn. About the Opportunity: Start Date: ASAP Schedule: Full Time or Part Time Hours: 12am - 8am Setting: Stabilization... 

Sid Potts, Inc

Administrative Assistant Job at Sid Potts, Inc

 ...grow into higher level roles i n the organization! Role Description This is a full-time ON-SITE ONLY role for an Administrative Assistant to the leadership team, with additional role supporting other departments and team members as assigned. Duties and Responsibilities... 

Jersey Hired

Interior Designer Job at Jersey Hired

 ...Jersey Hired is currently representing a leading architecture and design firm in the search for an experienced Hospitality Interior...  ...everything they do. From internal design competitions and art exhibits to well-being initiatives, they foster a balanced and engaging... 

Legacy Interviews

Administrative Assistant Job at Legacy Interviews

 ...future generations can see and hear their family talking about their past. Administrative Assistant Role: We're hiring a flexible, part-time administrator (1099 contractor role, no benefits; ideally 2+ years). Perfect for a former professional returning to work...