Our client is a leading North American manufacturer of home and personal care products, such as unit dose, disinfectant wipes, all-purpose cleaners, facial wipes, and baby wipes. With nine manufacturing plants and warehouses in North America, the company provides customers with private label solutions and contract manufacturing services for products found in retail and institutional markets.
Throughout the years, the company has built robust quality systems, multiple GMP certifications, and in-house FDA/EPA microbiology, quality control, chemistry, and R&D labs.
Regulatory Affairs Manager Background:
The position of the Regulatory Affairs Manager is responsible for leading the company’s overall regulatory strategy and direction in the area of premarket regulatory submissions and new product development. Deliver a world-class regulatory service to the business by creating and supporting a regulatory compliant culture and provides advice and counsel to management. This individual will work with cross functional departments to ensure that all products are in compliance with the appropriate government agency requirements and will represent Regulatory in project team meetings and provide the relevant guidance to Marketing.
Regulatory Affairs Manager Responsibilities:
• Responsible for regulatory compliance in the US (state and federal agencies) and Canada.
• Strong working knowledge of EPA regulatory and policy issues, and compliance requirements.
• Provide regulatory guidance, risk assessment and management throughout the entire product lifecycle.
• Perform label reviews against EPA master labels for all disinfectant/pesticide products.
• Responsible for FDA Notifications, Minor Formulation Amendments, New Product and Active Ingredient Registrations.
• Monitor legislative changes, new guidance documents, and review activities related to products and communicate internally.
• Responsible for overseeing nationwide registrations and renewal of pesticide products.
• Review changes in existing products to determine need for new/revised submissions or document is necessary.
• Complete state registration process for all new disinfectant/pesticide products.
• Manage yearly renewal process for all existing disinfectant/pesticide products.
• Assist with modifications to both CSFs and Master Labels for all sub registrations.
• Manage the database for Adverse Effects Reporting, preparation of submissions in accordance with federal, state, and international requirements.
• Investigate and resolve compliance issues, questions, or complaints received from internal departments, external customers, and government agencies.
• Assist in the development, review and approval of advertising and product label copy including reviewing and approving advertising and promotion material ensuring it is consistent with approved claims for regulated products.
• Manage the Hazard Communication process including the implementation of Safety Data Sheets through the UL WERC Smart system.
• Train and supervise department staff, evaluate staff performance, and develop goals and objectives for staff and provide routine evaluations of progress toward these goals.
• Identify and promote professional growth opportunities for staff.
• Ensure adherence to professional standards and ethics.
• Create and maintain policies and procedures for the department.
• Create R&D Content for regulated labels for compliance including net quantities.
• Provide updates and revisions.
Regulatory Affairs Manager Qualifications:
• Bachelor’s Degree & 3-5 years’ experience in the cosmetic, home care, medical device, pharmaceutical or medical product regulatory agencies; Demonstrated knowledge of regulatory issues and experience interfacing with federal, state, local & internationals regulatory bodies, such as USEPA, FDA, Health Canada, etc.
• Submission of forms to regulatory authorities including:
-EPA and FDA (Notifications, Minor Formulation Amendments, New Product and Active Ingredient Registrations).
-CA Prop 65
-FTC - Fair Packaging and Labeling Act – Flushable - Made in USA
• Actively participate as team member on all assigned new product introductions.
• Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals.
• Ability operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment.
• Ability to work well independently and in a team setting.
• Proven analytical, evaluative, and problem-solving abilities.