Regulatory Affairs Specialist

Lbb-Specialties-Holdings-LLC; Norwalk (CT); Hybrid; USD 70,000 - 110,000; Full time

Job summary

LBB Specialties is seeking a Regulatory Affairs Specialist to support regulatory submissions and functions. You will review and summarize U.S. state/federal and Canadian regulations, and act as a research assistant to the Regulatory Affairs Manager.

You will subscribe to regulatory news portals, review SDSs and labels for accuracy, and assist in drafting SOPs. This role requires 3+ years of regulatory experience and strong written and verbal communication skills.

Qualifications

• Bachelor’s degree and 3+ years of regulatory related experience, pharmaceutical/food/chemical industry preferred.
• Thorough understanding of regulations as they apply to writing and reviewing SDSs and labels.
• Trained in OSHA/DOT/IATA and related hazard safety regulations.
• Strong regulatory research skills for U.S. Federal and State regulations and Canada.
• Excellent computer skills including Outlook, Excel, Word, PowerPoint.
• Familiarity with TSCA, OSHA, FSMA; REACH and Canadian regulations.

Responsibilities

• Regulatory/legal research; ability to research, interpret and summarize relevant provisions.
• Subscribe to regulatory news portals, read the news, and submit summaries to Director of Regulatory Affairs daily.
• 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 regulatory committees such as NACD and RDC, summarize regulatory news/topics.

Skills

Regulatory research

SDS & Labels

Hazard regs

MS Excel

Regulatory portals

Education

Bachelor’s degree in regulatory affairs

Tools

MS Office

Job description

Regulatory Affairs SpecialistWhy 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 ImpactAs 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 ResponsibilitiesRegulatory/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 filesAssist 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 BringBachelor’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 HereCompetitive Benefits: Comprehensive healthcare, 401(k) matching, and more.Flexible Work Environment: Hybrid work scheduleProfessional 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 InformationLocation: Norwalk, CTTravel: NoneWork Authorization: Must be able to show evidence of authorization to work in United States without employer sponsorship.EEO StatementLBB Specialties is committed to providing equal employment opportunities for all employees and applicants, celebrating diversity and fostering a supportive, harassment-free work environment.DisclaimerThis job description is not exhaustive and may be subject to change or additional responsibilities based on business needs.