Conducts compliance reviews for Kao mass market products ensuring compliance with local, state, federal, and international product regulations for over the counter (OTC) drugs, cosmetics, and other consumer items in lead markets (USA, Canada, EU and Australia).
Conduct Product Registrations and\or Notifications in the regions we serve
Provides Artwork Flow\Label Review and expertise for mass market products in all regions for those brands assigned to them.
Review, proof, and approve/reject copy documents, labels, ads, web material, and promotional materials for cosmetic and drug products to confirm regulatory compliance to applicable regulations set by US FDA, Federal Trade Commission (FTC), Health Canada and other local regulatory agencies in the appropriate area of intended distribution. Review and approval of formulas for distribution in additional markets as requested by sales or marketing.
Perform drug product registrations, facility registration activities, or applications for drug product licensing with Food & Drug Administration (FDA), Health Canada, and or regulatory agency. Assess the level of risk associated with regulatory non conformance issues.
In-depth knowledge of regulations that affect drug and cosmetic production such as sunscreen or other monograph products. Able to interpret the requirements and clearly communicate the impact to Kao Products.
Support legal or product safety in investigation of non compliance of product formulation.
Participation at Trade association, informing Kao of future regulatory issues.
Work with outside consultants/agencies regarding areas of product labeling compliance that are not clearly defined in the regulations or that may be new areas being pursued by Kao US.
Participate in larger projects and teams to support commercialization of Kao Products.
Manage external Relationships with consultants.
Bachelor Degree (BS or BA) in Science such as Regulatory Sciences, Chemistry, Biology, or related field science.
At least 5 years’ experience in regulatory affairs in a personal care products or food company.
Multi-year experience with the regulatory climate in each of the USA, Canada and the EU.
Knowledge of European and US regulatory framework is essential.
Candidate must be resourceful, detail oriented, strong written and oral communication, good listening skills.
Able to read, understand, and interpret written regulations for application to Kao US products.
Collaboration skills between internal departments.
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