Regulatory Affairs Specialist

LBB SPECIALTIES HOLDINGS LLC•York Township, OH

23h•Hybrid

About The Position

As a Regulatory Affairs Specialist, you will be responsible for assisting the Regulatory Affairs Manager in regulatory submissions and functions. The Regulatory Affairs Specialist will also act as Research Assistant by reviewing and summarizing relevant U.S. state/federal and Canadian regulations.

Requirements

Bachelor’s degree and 3+ years of regulatory related experience, pharmaceutical/food/chemical industry preferred.
Have a thorough understanding of regulations as they apply to writing and reviewing SDSs and labels.
Trained in occupational hazard safety and transportation hazard safety regulations (OSHA/DOT/IATA, etc.).
Skilled and experienced in regulatory/legal research; ability to research, interpret, and summarize relevant provisions. This applies to U.S. Federal and State regulations as well as foreign regulations, specifically Canada.
Excellent computer skills including (Microsoft Outlook, Excel, Word, PowerPoint).
Knowledge of TSCA, OSHA, and FSMA regulations.
Familiarity with agency electronic portals FURLS, ODGI, CDER Direct, CDX, etc.
Familiarity with monographs; USP, FCC, NF & others.
Familiarity with REACH and Canadian regulations.
Excellent attention to detail, follow through, organization, time management, and written and verbal communication skills.
A proactive, results-driven approach with the ability to work both independently and collaboratively.

Responsibilities

Regulatory/legal research; ability to research, interpret and summarize relevant provisions.
Subscribe to all relevant regulatory news portals, read the news, and submit summaries to Director of Regulatory Affairs on a daily basis.
Review SDSs and Labels for completeness and accuracy.
Research regulatory questions for Principal Managers and Sales Representatives.
Perform weekly checks for import alerts and FDA 483 letters to determine if Company suppliers have been listed.
Assist in drafting Standard Operating Procedures and Work Instructions for regulatory functions.
Act as backup to Regulatory Affairs Manager.
Maintain current and orderly files
Assist in submitting Regulatory reports to agencies.
Assist in identifying and implementing process improvement initiatives.
Join relevant regulatory committees such as NACD and RDC, summarize regulatory news/topics and submit to Regulatory Affairs Manager.