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 consumer items in lead markets. Conduct Product Registrations and\or Notifications in the regions we serve while providing Artwork \Label reviews an expertise for mass market products in all regions we serve. Advance Kao's agenda utilizing global regulatory knowledge and Trade Association influence.
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.
Manage Projects that are need to improve the performance of Regulatory affairs. while Perform drug product registrations, facility registration activities, or applications for drug product licensing with Food & Drug Administration (FDA), Health Canada, and or regulatory agency.
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.
Lead legal or product safety in investigation of non compliance of product formulation.
Review and approval of formulas for distribution in additional markets as requested by sales or marketing. Whilst assessing the level of risk associated with regulatory non conformance 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. Influence Trade associations.
Be a force of influence with outside Trade associations such as PCPC, CE, CCTFA.
Manage internal contractors and external relationships with consultants and Trade Associations.
Bachelor Degree (BS or BA) in Science such as Regulatory Sciences, Chemistry, Biology, or related field science.
At least 7 years’ experience in regulatory affairs in a personal care products or food company.
The candidate should have multi-year experience with the regulatory climate in each of the USA, Canada and the EU.
Regulatory expertise such as : REACh, VOC, Chemical inventories, Cosmetics and OTC Regulatory Knowledge, Artwork Flow\Label Review expertise, Product Registrations and Notifications Expertise.
Knowledge of European and US regulatory framework is essential.
It desirable to have some exposure to other regulations such as FIFRA, Household products and Consumer Goods regulations.
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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