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Job description / Role
Regulatory Affairs Officer - Lubricant Additives, Epoxy Paints & Coatings
• Ensuring consistency, completeness, and adherence to standards for all regulatory submissions.
• Maintain up-to-date knowledge of international and domestic regulatory requirements.
• Perform Regulatory Affairs activities ensuring compliance with FDA, and other regulatory updates on the latest changes.
• Liaising with the FDA and REACH or other regulatory authorities, to monitor the progress of regulatory submissions, respond to queries, and ensure that registration approvals are granted without undue delay.
• Manages the process for case analytics and implements new methodologies to identify patterns and trends concerning important regulatory topics.
• Review Engineering Change Requests, Document Change Requests, Labeling, Variances, and other Quality System documentation that requires regulatory review and approval to ensure compliance with national and international government regulations.
• Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports.
• Update RA responsible quality system procedures as required (SQP/SOP).
• Guide, direct, and lead a team of regulatory professionals in the development of strategic plans and regulatory submissions.
• Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies.
Requirements
• Minimum 5 years working in Chemical Raw Material products such as Lubricant Additives, Epoxy Paints & Coatings, Rubber/Carbon Black, Coating, Foam, and Adhesives within a regulatory affairs/ compliance environment.
• Bachelor’s degree in Chemical engineering, Chemistry, or a similar discipline required.
• Ability and desire to progress and represent Acorn Regulatory in an exemplary manner.
• A professional with positive and proactive influencing skills.
• A strong and proactive team player who thrives on working in a local & international environment.
About the Company
Built over a rich legacy of over 50 years in the Chemical Industry, Kemipex is a leading developer and supplier of technologically-advanced and economically-improved chemical products and solutions. Based in the Middle East, we are involved in business operations across the globe. Apart from being key players in several chemical sectors like food, pharma, coatings and advanced construction raw materials, we are primarily a leading market figure in the Lubricant industry. Complying with various industrial specifications, our potent resources and strong technological database help us maximize the reliability, efficiency and lifespan of our customers finished products.