Regulatory Affairs Specialist

Job Details

Job Location:

Norwalk - Norwalk, CT 06851
Salary Range: $31.25 - $36.06 Hourly

• 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.

• 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.

• 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.

Location:

Norwalk, CT
Travel:
None
Work Authorization:
Must be able to show evidence of authorization to work in United States without employer sponsorship.

LBB Specialties is committed to providing equal employment opportunities for all employees and applicants, celebrating diversity and fostering a supportive, harassment-free work environment.

This job description is not exhaustive and may be subject to change or additional responsibilities based on business needs.