Senior Regulatory Manager

Confidential Company; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Confidential Company in the United States seeks a Sr. Manager Regulatory & EHSS to lead global regulatory strategy for new and redesigned products, securing rapid approvals, managing lifecycle submissions, and providing executive dashboards on regulatory metrics.

The role mentors plants and cross-functional teams to ensure safe, compliant operations, drives environmental sustainability, ESG reporting, and continuous risk reduction across sites, while serving as a backstop to the Global EHS

Qualifications

• Bachelor's degree in a technical discipline (preferred chemicals/polymers)
• 5+ years regulatory compliance experience in chemicals/polymers or related industries
• Experience with TSCA, Prop 65, RoHS, Conflict Minerals, UL, FDA and related areas
• Strong organizational, communication, and project management skills
• Experience with SAP software systems; familiarity with Sphera Compliance Software

Responsibilities

• Lead formulation of regulatory strategies to expedite product approvals domestically and support international licensing/registration
• Maintain product approvals and complete notifications, amendments, listings and yearly reports globally
• Manage regulatory support throughout product life cycle and interface with government authorities
• Monitor regulatory activities worldwide to anticipate changes and align company responses
• Advise management on regulatory policy to minimize risk and competition
• Lead/Support ESG, sustainability reporting and related initiatives
• Be backup and deputy for Global EHS Director and drive safety improvements across sites
• Ensure site compliance with regulatory permits and annual reporting requirements (e.g., SARA 313)

Skills

Regulatory compliance

Project management

Communication

SAP

Sphera

Education

Bachelor's degree

Tools

SAP

Sphera

Job description

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.

• 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.
• 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