Regulatory Affairs Coordinator

LBB SPECIALTIES HOLDINGS LLC•York Township, OH

9d•$28 - $32•Hybrid

About The Position

The Regulatory Affairs Coordinator maintains continued certification for BRC and ISO quality schemes, including reviewing and updating documentation, and manages compliance with governmental regulations and industry standards. The role also supports the sales team by completing customer quality questionnaires and responding to documentation requests. The position is based in Norwalk, Connecticut, with a hybrid work schedule and no travel. The successful candidate must show evidence of authorization to work in the United States without employer sponsorship.

Requirements

Bachelor’s degree and 1–3 years of regulatory-related experience.
Thorough understanding of regulations as they apply to writing and reviewing SDSs and labels.
Training in occupational hazard safety and transportation hazard safety regulations, such as OSHA, DOT, and IATA.
Experience and skill in regulatory and legal research, including researching, interpreting, and summarizing relevant provisions of U.S. federal and state regulations and foreign regulations, specifically Canadian regulations.
Excellent computer skills, including Microsoft Outlook, Excel, Word, and PowerPoint.
Knowledge of TSCA, OSHA, and FSMA regulations.
Excellent attention to detail, follow-through, organization, time management, and written and verbal communication skills.
A proactive, results-driven approach and ability to work independently and collaboratively.
Must show evidence of authorization to work in the United States without employer sponsorship.

Nice To Haves

Regulatory-related experience in the pharmaceutical, food, or chemical industry.
Familiarity with agency electronic portals such as FURLS, ODGI, CDER Direct, and CDX.
Familiarity with monographs, including USP, FCC, and NF.
Familiarity with REACH and Canadian regulations.

Responsibilities

Maintain certifications for ISO, BRC, and governmental requirements.
Research, interpret, and summarize relevant regulations and guidance documents.
Subscribe to relevant regulatory news portals, review updates, and submit summaries as requested.
Review safety data sheets (SDSs), labels, certificates of analysis (CoAs), and specifications for completeness and accuracy.
Work with Sales to provide regulatory assistance and documentation for customers and their requests.
Assist in drafting Standard Operating Procedures and Work Instructions for regulatory and quality functions.
Maintain current and orderly files.
Assist in submitting regulatory reports to agencies.
Assist in identifying and implementing process improvement initiatives.
Perform other job-related duties as assigned.