Regulatory Affairs Specialist

Regulatory Affairs Specialist

LBB SPECIALTIES HOLDINGS LLC

Norwalk, CT Job Details $31.25 - $36.06 an hour 1 hour ago Benefits Health insurance 401(k) matching Qualifications OSHA (regulatory compliance area) Microsoft Excel Microsoft Outlook Procedural guides Process optimization Writing skills Process improvement Mid-level 3 years Regulatory legal research DOT (Department of Transportation) regulations Bachelor's degree Legal research Regulatory submissions Communication skills File organization FDA regulations Time management Full Job Description Regulatory Affairs Specialist Why Join Us? At LBB Specialties, we are dedicated to empowering innovation, building meaningful relationships, and fostering an environment where every team member can thrive. As part of our team, you'll work alongside industry experts, contribute to impactful projects, and help drive our company forward in the chemical distribution space. Join us as we bring innovation and growth to the forefront of our industry. Your Impact 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. Key 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. What You'll Bring 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.

Why You'll Love Working Here Competitive Benefits:

Comprehensive healthcare, 401(k) matching, and more.

Flexible Work Environment:

Hybrid work schedule

Professional Development:

Access to learning opportunities and resources to grow in your career.

Inclusive Culture:

Be part of a diverse, collaborative, and supportive team.

Industry-Leading Impact:

Work with top brands in a dynamic field and contribute to meaningful growth.

Additional Information Location:

Norwalk, CT Travel:

None Work Authorization:

Must be able to show evidence of authorization to work in United States without employer sponsorship. EEO Statement LBB Specialties is committed to providing equal employment opportunities for all employees and applicants, celebrating diversity and fostering a supportive, harassment-free work environment. Disclaimer This job description is not exhaustive and may be subject to change or additional responsibilities based on business needs.