Regulatory Affairs Coordinator

Description

LBBS Overview

LBB Specialties LLC (“LBB Specialties” or the “Company”) is ranked in the top 4 of dedicated North American specialty chemical and ingredients distributors. The LBB Specialties (LBBS) platform has been built through seven acquisitions since 2017.

LBB Specialties is a leader in North American specialty chemicals and ingredients. It is a diversified supplier serving end-markets including care, food & nutrition, industrial specialties, and life sciences. LBB Specialties generates approximately $500 million in revenue annually and employs more than 110 commercial team members.

LBB Specialties is a subsidiary of LBB Industries LLC (“LBB Industries”). LBB Industries is a private firm whose objective is to create value by partnering with management teams to build and grow companies over the long term. LBB Industries’ capital and resources are dedicated to supporting the growth of its companies, including by seeking complementary acquisitions.

To learn more about LBB Specialties, please visit our website: https://www.lbbspecialties.com

Overview

The Regulatory Affairs Coordinator (RAC) will be responsible for maintaining all aspects of continued certification for the BRC and ISO quality schemes including reviewing and updating current documentation. Additional duties will include managing compliance with governmental regulations and industry standards. The RAC will also support the sales team by completing customer quality questionnaires and document requests.

Responsibilities

1. Lead [division’s] Regulatory/Quality functions.
2. Maintain certifications for ISO, BRC, and governmental requirements.
3. Regulatory/legal research; ability to research, interpret and summarize relevant and applicable regulations and guidance documents.
4. Subscribe to all relevant regulatory news portals, read the news, and submit summaries as requested.
5. Review SDSs and Labels, CoAs and Specs for completeness and accuracy.
6. Work with Sales to provide necessary assistance and documentation for customers in reference to regulatory aspects and customer requests
7. Assist in drafting Standard Operating Procedures and Work Instructions for regulatory/quality functions.
8. Maintain current and orderly files
9. Assist in submitting Regulatory reports to agencies.
10. Assist in identifying and implementing process improvement initiatives.
11. Perform other job-related duties as assigned

Education and Experience

• Bachelor’s degree preferred: study of chemistry or the physical sciences ideal.
• 2-3 years of regulatory related experience, pharmaceutical/food/chemical industry preferred.

Knowledge and Skills

• 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, including Canada
• Excellent computer skills including (Microsoft Outlook, Excel, Word, PowerPoint, pdfs).
• 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.
• Excellent written and verbal communication skills.
• Excellent organizational and time management skills.

Personal Attributes

• Personal integrity. The highest standard of personal and professional conduct.
• Entrepreneurial mindset coupled with business discipline.
• Natural curiosity. Commitment to learning and growth – both personally and within others.
• Ability to work in a fast-paced, dynamic environment with demonstrated ability to timely manage multiple projects and tasks.

Additional Information

Location: Norwalk, CT (hybrid schedule after 90 days)

Hours: 8:30AM - 5:00PM

FLSA Status: Full-Time, Non-Exempt

Travel: None

Work Authorization: Must be able to show evidence of authorization to work in the US without employer sponsorship

EEO Statement

We are committed to providing a fair and equal employment opportunity for all employees and job applicants regardless of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, marital status, disability, medical history or genetic information, military service, or other non-merit based factors. We believe that employees should be provided with a working environment that fosters productivity and the ability to work to the best of his/her ability. We do not condone or tolerate an atmosphere of intimidation or harassment based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, marital status, disability, medical history or genetic information, military service, or other non-merit based factors. We expect and require the cooperation of all employees in maintaining a discrimination and harassment-free atmosphere.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required and these may change from time to time.

Qualifications

Salary : $500