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

Russell Tobin

Administrative Assistant Job at Russell Tobin

Job title: Administrative Support Location: Salt Lake City, UT Duration: 6months Pay rate: $28-$29/hour Position Description: Job Summary & Responsibilities: Provide administrative support to in a team-oriented environment; Flexibility to support varying...

Sweetcarolinatravels

Remote Travel Consultant Job at Sweetcarolinatravels

 ...As a Remote Travel Consultant, youll play a mission-critical role in supporting our clients from their very first trip idea all the way to their safe return home. Youll be the steady, knowledgeable guide who keeps their travel experience seamless, stress-free, and genuinely... 

Pocketbook Agency

Office Manager for Retail Company Job at Pocketbook Agency

 ...friendly Office Manager for a successful and fast growing e-commerce company based in Hollywood, Los Angeles. You will be the first point of...  ...visibility for key team Partner with People & Culture on new hire prep tasks, including paperwork and building/parking card setup,... 

System One

Mechanical BIM Coordinator Job at System One

Position: Mechanical BIM/VDC Specialist Location: Phoenix, AZ (85029) Pay: $70k - $80k Summary: Piping VDC/BIM professional specializing in coordinated modeling, shop drawings, and constructability support to improve project accuracy, efficiency, and field execution...

Unigen Corporation

Vice President of Global Supply Chain & Logistics Job at Unigen Corporation

 ...Job Title: Vice President of Global Supply Chain & Logistics Location: Newark, CA Department: Procurement Reports to: Vice President...  ...business. This includes procurement, logistics, inventory management, demand planning, supplier relations, and cost management...