Regulatory Specialist

POSITION DESCRIPTION

Job Title: Regulatory Affairs and Quality Systems Specialist

Reporting: Continuous Improvement Leader

Date: July 2024

Duties and Responsibilities:

• Ensure regulatory compliance and maintain high-quality standards across multiple sites.
• Stay abreast of relevant regulations, guidelines, and standards applicable to specialty chemicals.
• Monitor and review new and existing laws, regulations, and guidelines relevant to our products.
• Analyze the impact of regulatory changes on our operations and products.
• Interpret and communicate regulatory requirements to internal stakeholders.
• Conduct regulatory assessments for new products and changes to existing products.
• Provide regulatory guidance and support to resolve compliance issues and inquiries.
• Work closely with R&D, Production, Supply Chain, and Sales teams to ensure regulatory compliance and quality standards are met throughout the product lifecycle.
• Prepare regulatory requirements and updates for entry into the site ERP system.
• Develop training materials on regulatory and quality topics for employees.
• Prepare and/or update regulatory affair supplier questionnaires for produced materials as requested for new and existing customers.
• Develop, maintain, and update accurate SDS for our product portfolio.
• Distribute new and updated SDS's to internal and external customers as required
• Ensure SDS compliance with global regulatory requirements (e.g., OSHA, REACH, GHS).
• Assist in the implementation, maintenance, and improvement of the Quality Management System.
• Conduct internal audits and support external audits related to regulatory compliance, quality assurance, and ISO9001 compliance.
• Be the process expert and owner of the company's QMS software and associated processes.
• Maintain accurate documentation related to regulatory compliance and quality assurance activities.
• Other duties as directed by the management.

Skills, Qualifications, Experience, Special Physical Requirements:

• Bachelor's degree in chemistry, Chemical Engineering, Regulatory Affairs, or a related field (advanced degree preferred).
• Proven experience (3+ years) in regulatory affairs and quality assurance within the specialty chemicals industry.
• Strong knowledge of global regulations and standards (e.g., REACH, OSHA, GHS).
• Experience creating SDS and familiarity with SDS authoring software.
• In depth knowledge of ISO9001 compliance related to specialty chemicals
• Strong computer skills and experience with a QMS software system
• Excellent analytical skills and attention to detail.
• Effective communication and interpersonal skills to collaborate across departments and with regulatory agencies.
• Ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.