Regulatory Affairs Specialist

2 weeks ago


Charlotte, North Carolina, United States CEO Inc. Full time
Regulatory Affairs Specialist

At CEO Inc., we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring that our products meet specific safety, compliance, and customer acceptance criteria.

Key Responsibilities:
  • Obtain and review new raw material documentation from suppliers to catalog into our ERP System.
  • Contribute to our Global Regulatory Group by assisting with National regulatory matters.
  • Define regulatory constraints, safe handling and storage requirements, proper disposal methods, and shipping classification for finished materials.
  • Develop a deep understanding of our Color and Additive department strategies to accelerate new product introductions and boost launch efficiency.
  • Provide regulatory strategy input to project teams and assist in development of project objectives.
  • Oversee the effectiveness and compliance of new employee safety training.
Quality Management:
  • Maintain the integrity of our Quality Management System according to ISO 9001:2015.
  • Work closely with Production, Engineering, and Quality teams to ensure compliance.
  • Lead customer reviews/quality audits and lead quality audits/reviews via relevant regulatory agencies.
  • Communicate best practices to promote systemic improvements and establish good communication internally and externally.
  • Identify, create, and manage controlled documentation, processes, and checklists.
  • Prepare and conduct internal audits at scheduled intervals and review relevant corrective actions/nonconformances.
Competencies:
  • Approve or recommend rejection of developmental products and new raw materials based on safety, health, and compliance risks.
  • Monitor Regulatory Literature for changes and develop internal policies related to external affairs.
  • Successfully communicate across regions and functions, providing clarity on new substance notification strategies, data requirements, statuses, and timelines.
  • Employ hazard mediation and advocacy skills to ensure agency regulations and risk management controls on company products and substances are in compliance.
  • Competency with respect to global regulations governing chemical management, chemical hazard communication, chemical use, dangerous goods transportation, and banned/restricted substances.
  • Understanding of worldwide chemical-control regulatory requirements for the manufacture, distribution, and sale of chemical products to help the company meet regulatory deliverables within commercialization program deadlines.
  • Respond to customer and other external requests related to product declarations and certifications.
  • Monitor emerging regulatory requirements and industry trends to advise business units on portfolio impact and opportunities.
  • Coordinate with third-party consultants, as needed, to enable compliance with global regulations.

Requirements:

  • Bachelor's in chemistry/biology or relevant field.
  • A minimum of 5 years' experience in product regulations and/or regulatory affairs or related field impacted by EHS.
  • Knowledgeable in GHS, Hazard Communications Standards, California Proposition 65, and Food Contact Regulations.
  • Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
  • Willingness to participate in training and continuing education required.
  • Ability to write and present information in one-on-one and small group situations to customers, vendors, and other company employees.
  • Effectively communicate/interact with all levels of employees in a professional manner.
  • Ability to work independently with little to no supervision or as a member of a team.
  • Ability to use an ERP System for data-entry and documentation, and to generate reports.
  • Must have attention to detail, strong organizational skills, and the ability to prioritize the workload.


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