The Head of Global Regulatory Affairs takes a “hands-on” leadership role in defining and implementing regulatory strategies and initiatives that support the Company to maximize business opportunities while ensuring compliance with current and future regulations. In addition to securing appropriate regulatory approvals for key technologies and formulations, the position supports a diverse and growing demand for expertise and services related to compliance and certifications with partners, regulatory agencies, industry groups, and outside contractors.
- Provides strategic regulatory advice and oversees the Company’s registration plans to help it maximize business opportunities.
- Maintains a working knowledge of current and future regulations that affect the Company’ business
- Manage US and international (ECHA, EPA, Country/State regulations, food contact-type, etc.) registrations and notifications to maintain and expand the global registrations portfolio.
- Prepares and submits regulatory information to appropriate authorities, working with third party microbiology labs, regulatory consultants and government regulatory agencies (such as EPA and similar in other countries) to align the proper test methods and protocols with the various regulatory standards for achieving specific label claims and approvals.
- Represents the Company before regulatory authorities and industry associations such as the American Chemical Council and the Household and Commercial Products Association.
- Maintains orderly and accurate records, files, and documentation related to regulatory affairs, safety, and compliance activities, in close collaboration with Quality department.
- Review competitive claims evidence and assist in the development and approve marketing materials, education programs.
- Review product labels as well as claims for marketing and sales literature and electronic content to ensure compliance by The Company’s companies and their customers with regulatory requirements and company standards. Prepares summary materials (presentations, reviews, etc.) for the Marketing and Sales Departments. When required, participates in meetings and calls with vendors/customers/prospects, directing them to key information resources.
- Reviews elements of contracts that relate to regulatory compliance as requested by the Legal Department.
- Prepares and provides documentation to third parties related to regulatory law and compliance for inventory certifications, food contact approval status, and others, as requested.
- Prepares and submits applications, dossiers, or other data packages to obtain third party certifications or others requested by the businesses.
- Coordinates insight gathering globally and contributes to the development of brand, product, and chemical ingredient strategies.
- Provides operational support for new product development. Reviews and recommends potential new materials for Research and Development and assists with experimental design in product support studies
- Reviews technical closures, raw material/new product activations.
- Trains new hires on regulatory system, procedures, and expectations; provides annual refresher training to all required employees.
- Keep abreast of new technologies through conferences and/or literature and acts as a microbiology area resource.
- Ensure budgets, timelines, compliance are part of company plans.
- Set a personal example of high ethics and work standards.
- Bachelor’s degree (B.S.) minimum or master’s degree (M.S.) preferred in Chemistry, Biology, Environmental Science, or related sciences. Certifications and membership to (RAPS, Society of Toxicology,) is a plus.
- A minimum of 10 years of experience in regulatory affairs/compliance, product safety, or closely related fields. EPA and FIFRA regulatory experience with biocides required. Regulatory and registration knowledge in EU (BPR), Australia, and New Zealand is highly valuable.
- Knowledge related to efficacy and safety microbiology testing of antimicrobial products and chemical safety, toxicological and environmental testing of chemicals. Ability to manage the work of external labs, including study design and protocols.
- Experience and competence in effectively representing the company with key third parties (trade associations, technical groups, testing labs, etc.)
- Must have excellent oral and written communication skills and proven ability to engage external and internal stakeholders to support the company’s strategy. The incumbent will need to communicate technical data across multiple audiences and culture.
- Proven leadership skills in a cross-functional team environment. Knowledgeable in management and administrative processes with proven ability to translate strategies into action plans that deliver the company’s goals (strong strategy and execution skills).
- High energy individual with a strong work ethic; an entrepreneurial, hands- on, action-oriented executive who inspires the organization to challenge the status quo and unlock improvement opportunities wherever found.
- Problem Solver. With new business opportunities being developed at a fast pace, speed in technical validation is paramount.
- Proficient with MS Office and data analysis tools.
- Travel required: up 25-30%, domestics and international.