Senior Regulatory Manager

The Sr. Manager Regulatory & EHSS manages the implementation of global strategy and tactics for new and redesigned products to obtain rapid regulatory approval of submissions in all countries; directing and managing operational administrative regulatory functions for product support through the product life cycle; providing executive management with regulatory metrics/information; and providing regulatory knowledge to other functions. Additionally, they are responsible for serving as a mentor for the plants and other functional groups in order to ensure a safe and healthy workplace while driving continuous improvements in the areas of risk reduction and safety systems. Other responsibilities include leadership in environmental sustainability and regulatory reporting.

Essential Duties & Responsibilities (Regulatory)

• Lead the formulation of regulatory strategies to expedite the approval/clearance of products domestically and supports the licensing and registration internationally; ensures submissions are made to regulatory agencies that get products rapidly approved or cleared to market.
• Maintains product approvals and completes all necessary notifications, supplements, amendments, listings and yearly reports required for products on a global basis.
• Manages regulatory support through product life cycle.
• Is able to interface with government authorities for the discussion of adverse events, general questions or approval of product.
• Monitors activities of government regulatory authorities on a worldwide basis to assure company is able to align and support or anticipate changing regulations.
• Develop least cost, least time means to provide optimal regulatory support for new products in order to maximize selling opportunities in countries.
• Counsel management on regulatory policies so as to minimize competition and minimize risk to division.
• Manage Safety Data Sheet systems to ensure up to date SDS are available for raw materials and products. Create SDSs as needed.

Essential Duties & Responsibilities (EHS)

• Improve and Upgrade all things related to New Product Introduction and Transfer of Raw Materials and Finished Goods across our locations
• Ensure that proper MSDS, SDS and TDS are up to date with an effective system to provide accurate and readily available information as needed throughout the organization in a sustainable storage process.
• Assist as needed with UL and NSF certifications
• Lead/Support ESG, Sustainability reporting, and initiatives
• Be full backup and next in command for Global EHS Director
• Maintain and Drive Improvement related to Environmental Responsibility
• Reporting and Recognition Assist and be active in Safety Initiatives and Tracking of Metrics
• Be actively involved with case management for plant incidents
• Ensure that each site is in compliance with all regulatory permits and have an effective and accurate system for tracking this while driving continuous improvement
• Responsible for ensuring that all sites are compliant with required governmental annual reporting (SARA 313, etc)

Requirements:

• Bachelor’s Degree in a Technical Discipline with a preference for Chemicals or Polymers Engineering.
• 5 years of regulatory compliance experience in the chemicals, polymers, or similar materials industries. Previous technical experience in R&D, Product Engineering, or Environmental a plus.
• Experience with TSCA, prop 65, RoHS, Conflict Minerals, UL, FDA and more compliance areas
• Strong organizational, communication, and project management skills.
• Competency in SAP Software Systems
• Experience with Sphera Compliance Software preferred