What are the responsibilities and job description for the Regulatory Affairs Specialist position at LBB SPECIALTIES HOLDINGS LLC?
Job Details
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.
Qualifications
What You’ll Bring
- Bachelor’s degree, preferably in Life Science or a chemical related field
- At least 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.
- 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.
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 (Hybrid, 3 days in office)
- Work Authorization: Must be able to show evidence of authorization to work in the U.S. 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.
Salary : $34 - $38
