Regulatory Affairs Specialist

4 weeks ago

Charlotte, United States CEO Inc. Full time

Position: Regulatory Affairs Specialist

Location: Greater Charlotte, NC Area

Position Summary and Purpose:

The Regulatory Affairs Specialist, under the direction of the R&D manager, is responsible for ensuring that all newly launched commercial products meet specific safety, compliance, sustainability, and customer acceptance criteria, which is directly proportional to the success of those products once commercialized, and to the financial objectives of the business. The successful candidate will provide support to Commercial, Marketing, Research and Development, and Technical Processes.

Essential Responsibilities:

  • Obtain and review new raw material documentation (SDS, TDS, FDA, etc.) from suppliers to catalog into ERP System
  • Contribute and harmonize as a member of Company 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 to create relevant documentation
  • Required regulatory reporting to designated governmental agencies
  • Develop a deep understanding of the Color and Additive department strategies, to accelerate new product introductions and boost launch efficiency
  • Provide regulatory strategy input to project teams and to peers, and assist in development of project objectives, and provide relevant regulatory requirement training
  • Oversee the effectiveness and compliance of new employee safety training

Quality Management – Preferable

  • Maintain integrity of the company’s Quality Management System according to ISO 9001:2015
  • Work closely with Production, Engineering, and Quality teams
  • Lead customer reviews/quality audits
  • Lead quality audits/reviews via relevant regulatory agencies
  • Communicate best practices to promote systemic improvements
  • Establish and maintain good communication internally & externally
  • Identification/Creation/Management of controlled documentation, processes, and checklists
  • Prepare/conduct internal audits at scheduled intervals and review relevant corrective actions/nonconformances.
  • Ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs), Working Instructions (WIs) among others, also creating SOPs, WIs, and updating/adhering to these as appropriate.

Competencies:

  • Approve or recommend rejection of developmental products and new raw materials based on safety, health and compliance risks
  • Monitoring Regulatory Literature for changes
  • Heads/develops/coordinates/advises on 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 world-wide chemical-control regulatory requirements for the manufacture, distribution and sale of chemical products to help 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

Knowledge & Skill 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.
  • 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. Work and function as a team member in a team-based environment.
  • Must have the ability to work independently with little to no supervision, or as a member of a team.
  • Ability to use an ERP System (Enterprise Resource Planning) 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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