Regulatory Affairs Coordinator
Regulatory Affairs Coordinator
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Job Description
Job Details
Description
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 youll 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 Coordinator you 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.
Key Responsibilities
- Lead Regulatory/Quality functions.
- Maintain certifications for ISO BRC and governmental requirements.
- Regulatory/legal research; ability to research interpret and summarize relevant and applicable regulations and guidance documents.
- Subscribe to all relevant regulatory news portals read the news and submit summaries as requested
- Review SDSs and Labels CoAs and Specs for completeness and accuracy.
- Work with Sales to provide necessary assistance and documentation for customers in reference to regulatory aspects and customer requests
- Assist in drafting Standard Operating Procedures and Work Instructions for regulatory/quality functions.
- Maintain current and orderly files
- Assist in submitting Regulatory reports to agencies.
- Assist in identifying and implementing process improvement initiatives.
- Perform other job-related duties as assigned
Qualifications
What Youll Bring
- Bachelors degree preferred: study of chemistry or the physical sciences ideal.
- 2-3 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 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.
Why Youll Love Working Here
- Competitive Benefits: Comprehensive healthcare 401(k) matching and more.
- Flexible Work Environment: Hybrid and remote work options within the U.S.
- 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(hybrid schedule after 90 days)
- 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.
Required Experience:
IC
Employment Type
Unclear
