Position: Product Safety Manager EH & S Job Code: 5319
Location: GOJO Plaza - Akron, Oh
Work Hours 8:30 a.m. to 5:00 p.m.
Less than 20% travel required
Position located at GOJO Plaza in Akron, OH
Nature of the work: Provides Product Safety and Toxicology support to meet department and corporate objectives for both on-going business and new product development. Work has primary emphasis on cosmetic and OTC Drug products on a national and international level. The primary process leader for establishing and aligning ingredient selection/deselection processes on a global basis. Reviews, develops and maintains product and Ingredient Safety Assessment Dossiers, primarily preclinical testing, for GOJO products and ingredients globally. This includes understanding domestic and international requirements to provide complete dossiers for registration and support regulatory inspections. Create and maintain accurate dossiers of GOJO products to support submissions from safety, toxicology and biocompatibility point of view.
• Manage/Perform Product and Ingredient Safety Reviews. Assure appropriate toxicology reviews are completed for products and materials, with feedback to the businesses.
• Conduct ingredient safety reviews in light of regulatory requirements. Develop Policies and guidelines consistent with these requirements to be used by the GOJO community.
• Manage registration including understanding requirements, accessing historical knowledge, and assembling historical information in appropriate format to support submission and updating product information with additions to product/material testing.
• Manage product safety testing with outside vendors.
• Assess historical product safety testing, identify gaps and recommend testing plans to positively impact current and new registrations.
• Educate businesses on actual requirements of testing and which standards apply to which products/materials. An understanding of the requirements by businesses will eliminate unnecessary requests and result in modifications of product specifications to remove incorrect requirements.
• Liaison between and various businesses to support product submissions to meet global requirements.
• Manage initiatives related to Green Chemistry, Life-Cycle and Product Safety, both internally as well as external to GOJO.
• Manage the generation of MSDS and other product safety collateral.
• Recommend and Implement computer/tolls solutions to manage Product safety issues and processes.
• Creates testing timelines and integrated development timelines.
• Implements GCP and GLP to all development programs.
• Manages projects to completion.
• Proacts to provide update on regulatory changes.
• Actively participates in trade association committees, which support company business needs and strategies.
• Participates in proactive efforts to influence emerging legislation. Forms, leads, and participates in project teams.
• Researches complex regulatory safety issues and provides guidance to entire organization.
• Conducts the copy review of labels, labeling and graphics, in accordance with regulatory requirements.
• Researches relevant regulatory requirements for drug development phases
• Provides regulatory support for preclinical safety testing, clinical protocol development and overall Good Clinical Practices adherence.
• Writes sections and complete modules of CTD dossier.
• Provides guidance to development teams on appropriate content and format of CTD deliverables.
• Compiles relevant IND (Investigational New Drug) applications.
• Compiles FDA non-clinical and Clinical Briefing Packages. Coordinates Agency Meetings.
• Performs label, product, formulation and performance change control evaluation for regulatory impact
Education and Experience Required
• BA/BS or higher technical degree required with at least five (5) to eight (8) years’ experience in product safety reviews.
• PhD, DABT (Diplomate, American Board of Toxicology) or Master’s in Toxicology or related life sciences, with five (5) years' direct or related product safety review background.
• Previous experience dealing directly with government regulatory agencies (especially EPA) and personnel a plus.
Additional General/Technical Skills Required
Must Have Knowledge Of:
• Major Product stewardship and safety aspects of skin care products, for both professional and consumer markets, including cosmetics, Over-The-Counter, and New Drugs
• Familiarity with global chemical registries, such as REACH
• Performs Good Clinical and Laboratory Practices
• CTD requirements as pertaining to the non-clinical safety and clinical parts
• Clinical Trial Design and Reporting, Preclinical safety requirements
• Technical writing
• Function, operation and interdependencies of research, marketing, and manufacturing with the Product safety and Regulatory function.
• Process aligning technical resources to support business objectives and customer needs.
• OECD standard protocols.
• Interpret business risk and opportunity arising from safety related issues and proactively generate appropriate responses.
• Industry and trade groups with information/expertise in areas of responsibility and methods of accessing.
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Recruiters, Search Agencies or others referring candidates to GOJO Industries, Inc. without written authorization from GOJO Industries, Inc. Human Resources will not be compensated in any way for their referral even if GOJO Industries, Inc. hires the candidate.
GOJO is an Affirmative Action/Equal Employment Employer M/F/D/V. Applicants must be lawfully authorized to work in the United States. GOJO does not seek or respond to unsolicited resumes sent electronically for positions that are not listed below.
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