Overview
The Regulatory Affairs Associate supports the Regulatory Affairs department with compliance documentation, change control activities, regulatory data management, and supporting regulatory documentation and dossier preparation related to cosmetic products and raw materials.
This role works closely with Regulatory Affairs, Quality, Product Development, Production, and Procurement to support formula documentation updates, raw material reviews, SDS preparation, PIF support activities, and internal compliance processes.
Responsibilities
● Assist with preparation and review of regulatory documentation including:
○ QQs (Qualitative/Quantitative formulas)
○ QILs (Quantitative Ingredient Lists)
○ Ingredient Lists (ILs)
○ Raw material documentation files
○ Regulatory spreadsheets and trackers
○ SDSs (Safety Data Sheets)
○ PIF (Product Information File) supporting documentation
● Support collection and organization of supplier documentation including:
○ SDS
○ COA
○ TDS
○ Allergen statements
○ Country of Origin statements
○ Additional compliance documentation as needed
● Assist in compiling and organizing documentation required for domestic and international product registrations
● Understand and interpret test reports such as preservative efficacy testing, heavy metals, stability, repeat insult patch testing, ocular testing, flash point, etc.
● Support formula and raw material change control processes
● Assist with updating pick lists and documentation related to approved formula revisions
● Support document updates related to formula revisions, supplier changes, and raw material updates
● Maintain and organize regulatory records, logs, trackers, and shared files
● Assist with manual document review and data verification using:
○ Excel
○ Google Sheets
○ Word
○ PDF files
● Work cross-functionally with QC, Regulatory, Product Development, Production, and Procurement to support documentation accuracy and consistency
● Support additional regulatory and compliance projects as assigned
Position Requirements
● Must be able to work on computer while sitting for up to 8 hours per day and document review work. Self motivated.
● Proficient with Microsoft Office Suite
● Good verbal communication and writing skills
● Ability to manage multiple projects and deadlines in a fast-paced environment
Core Competencies
● Bachelor’s degree is a plus.
● At least three years of personal care industry experience.
● Experience in cosmetic manufacturing, technical transfer, QC, Product Devel-opment, or related technical role preferred
● Knowledge of safety testing requirements for finished cosmetic and OTC drug products.
● Strong organizational skills and attention to detail
● Comfortable working with spreadsheets, databases, and document-heavy processes
● Ability to manage multiple tasks and follow established procedures
● Interest in Regulatory Affairs and cosmetic compliance
This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Pay: $60,000.00 - $75,000.00 per year
Benefits:
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
Work Location: In person
