Global Regulatory Compliance Specialist
4 days ago
About Power Dream
Power Dream is a leading player in the global Energy Curing industry, specializing in oligomers, monomers, and additives. With over two decades of experience, we prioritize innovation, eco-friendliness, substance, and responsibility. Our goal is to introduce cutting-edge technologies to diverse markets including graphic arts, coatings, nail care, adhesives, and electronics. We value exceptional customer care and attention, striving to address our customers' unique needs through value-added service.
Job Summary
This is a remote/hybrid role that requires a strong regulatory compliance background. The successful candidate will lead projects for the implementation of GHS regulatory standards, manage SDS systems, and ensure EPA and FDA compliance.
Key Responsibilities
- Regulatory Implementation: Lead projects for the implementation of GHS regulatory standards in accordance with OSHA 2012 and WHMIS 2015.
- SDS Systems: Implement new SDS authoring systems, templates, and labels.
- EPA Compliance: Handle the preparation and submission of EPA Chemical Data Reporting (CDR), facilitate EPA Section 11 site inspections, and manage compliance with EPA TSCA Sections 4, 5, 6, 8.12, and 13.
- FDA Compliance: Review FDA compliance and prepare documentation, including FCN dossier support and usage reviews.
- Consultant and Agency Liaison: Coordinate with external regulatory consultants, legal counsel, governmental agencies, and participate in chemical trade association councils.
- Regulatory Documentation: Review new and existing chemicals for market feasibility, evaluate market strategies, and advise on market rights.
- System Management: Manage the integration, maintenance, and testing of the SAP ERP system and WERCS Authoring.
- Reporting and Documentation: Prepare and submit U.S. Pre-Manufacturing Notifications (PMNs) and Canadian New Substance Notifications (NSN), along with regulatory reports such as Chemical Weapons reporting and TSCA Section 8.
- Training and Support
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