Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
The on-site position is available at any of our company's locations, including Taft, LA, Jersey City, NJ, Bradford, ON in Canada, or Izmir in Turkey.
What We Do:
Galata Chemicals is a specialty chemical company manufacturing and marketing additives, primarily used in PVC applications around the world. The business has been established for over 40 years with manufacturing and sales globally and became an independent Private Equity owned company in May of 2010. The Taft, LA, site is the hub for manufacturing, logistics, customer care, and technology in the Americas, and will also play a key role in the growth strategy of the company.
What You Will Do:
Galata Chemicals is seeking a highly skilled and motivated Regulatory Affairs Manager / Hazard Communications Manager to join our team. As a Regulatory Affairs / Hazard Communications Manager, you will be responsible for ensuring compliance with all relevant regulations and guidelines in the chemical production industry. Your role will involve project management, compliance management, quality assurance, and research to ensure that our products meet FDA regulations and other applicable standards.
· Reporting to VP/Technology, serve as a subject matter expert for chemical and product specific regulations to ensure regulatory compliance globally.
· Safety Data Sheet & Label Authoring as required using UL/Wercs software
· Product set up and Data Maintenance in EH&S SAP module
· Product Classification - Use relevant regulations to properly classify the Company products
· Regulation tracking - Keep current with the changing global regulations on hazard communications; communicate to the management in a timely manner relevant changes in global chemical regulations
· Regulations Implementation - Implement new regulations and maintain SDS’s and labels in compliance with the applicable laws and regulations to assure uninterrupted business operations
· Assure that SDS’s accurately reflect product compositions in SAP
· Provide necessary support with REACh registrations and compliance
· Maintain contact with 3rd party emergency responders and service providers
· Support activities for determining the proper shipping classification and packaging classification; capture and maintain the same in SAP
· Work closely with Business, Sales, Supply Chain, Quality and plant EH&S teams to provide regulatory support to the US operations
· Respond to day-to-day customer inquiries related to regulatory matters
· Educate/train company employees on regulatory matters to assure that the internal processes ensure compliance with applicable regulations
· Lead the company’s efforts in achieving and maintaining the Sustainability goals aligned with the industry standards
The Skills You Bring:
We offer competitive compensation packages, including benefits such as health insurance, retirement plans, and professional development opportunities. Join our team as a Regulatory Affairs Manager and contribute to ensuring the safety and compliance of our chemical products.
Galata Chemicals is an Equal Opportunity Employer
Job Type: Full-time
Pay: $60,533.05 - $72,900.02 per year
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Work Location: In person