Regulatory Affairs Consultant – Skin Care, Cosmetics, Biocides,

<ins>Position Purpose:</ins>Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives for client's business units, while ensuring compliance with domestic, regional and international cosmetic & personal skincare regulations. Provide regulatory training and strategic regulatory assessments to key stakeholders to enable R&D innovation pipeline. Deliver regulatory milestones consistently to the APAC region.<ins>Key Customers:</ins>Primary customers include APAC Professional business units including their respective management team, mill/plant operations and quality management teams, Regulatory Affairs, R&E, Legal, Quality Assurance, Global Clinical Affairs, Global Product Safety, Purchasing, Logistics, suppliers and contract manufacturers.<ins>Expectations and Responsibilities:</ins><ul><li>Develop and implement domestic, international, and where appropriate, product specific regulatory strategies in support of business objectives</li><li>Monitor the development of regulatory initiatives and communicate potential business impact to APAC RA manager</li><li>Provide an interpretation of regulatory requirements, both domestic and international to the APAC RA manager and highlight implications of differences with respect to product development and testing activities so as to minimize overall development activities while bring speed to the global registration process.</li><li>Conduct training seminars on domestic and international regulatory requirements and/or impending regulations to the appropriate business team members to enable the best global development activities (when required)</li><li>Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective action.</li><li>Assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes</li><li>Interpret regulatory rules or rule changes and ensure that they are communicated on a timely manner</li><li>Uses relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards and provide an interpretation of regulatory requirements to the appropriate business team members</li></ul><ins>Scope:</ins>Incumbent provides support to APAC RA manager. He/she provides direction, advice and assistance to the organization’s facilities, business sectors and team members on regulatory compliance and knowledge management. Incumbent is responsible for maintaining regulatory management systems designed to effectively and efficiently support business objectives. This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized quality and regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinates activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client business units.<ins>Qualifications/Education/Experience Required:</ins>A broad technical background is required; preferably a graduate level degree, or as a minimum, a bachelor’s degree in a major scientific discipline, preferably chemistry or microbiology and/or 5-8 years of relevant regional technical experience, including direct experience in compliance with APAC - ASEAN, Australia, New Zealand, Hong Kong, Taiwan, China and India cosmetic and/ or Biocide regulatory approval process. Experience with Cosmetics and / or Biocides is required. Additional experience with other product category regulations is highly desirable. Must be fluent in English, other European/ASEAN languages are desirable.<ins>Principal Accountabilities:</ins><ol><li>Participate on project teams developing/launching new products by defining regulatory requirements and develop regulatory strategies and/or complete assessments to ensure compliance and successful achievement of business objectives</li><li>Establish and maintain an information network for purposes of monitoring and maintaining a current knowledge base of regulatory intelligence ie existing/emerging/new regulations, standards, and guidance documents</li><li>Establish and maintain a process to ensure that Product Information Files (PIF) are prepared and maintained, accurately and completely and in a timely manner to meet business objectives</li><li>Establish and maintain a process to ensure that cosmetic formulated products are classified, Safety Data Sheets provided, artwork approved and product notification/registrations completed in all countries of sale, accurately and completely and in a timely manner to meet business objectives</li><li>Establish and maintain an information network for the purposes of monitoring APAC biocidal product and cosmetic regulatory developments.</li><li>Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances.</li><li>Establish and maintain a process to participate in the review of process/product changes, labeling, claims, complaints, etc., to ensure compliance to internal and international requirements</li><li>Perform other tasks and activities as directed by the APAC RA Manager.</li></ol>