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Junior Regulatory Affairs Executive

2 weeks ago

Bangkok, Bangkok, Thailand Amorepacific (Thailand) Limited Full time ฿1,200,000 - ฿2,400,000 per year

Job Responsibility


• Handle regulatory submission of new product, existing product by working with FDA, Marketing and Supply Chain team


• Compile dossiers for product registration and renewing of product licenses on a regular basis


• Prepare and submit regulatory notifications and registrations as required by the company's standards to ensure compliance and timely approval for market release of new and existing products


• Oversee processes involved with maintaining annual licenses, registrations, and listings


• Monitor and keep up to date with changes in relevant regulatory legislation and guidelines that may impact products and business strategies


• Arrange and update packaging artworks of registered products


• Liaise with the regulatory authorities to obtain registration certificate approval or amendment approval


• Liaise with the regulatory authority as well as overseas counterparts regards to regulatory affairs matters, including product registrations, variations to existing products and renewals


• Support logistics function regarding import products


• Answer inquiries regarding shipping regulations, correct product labeling, saleable product locations and promote good compliance practice


• Monitor post-market vigilance issues and take role in risk management/assessment


• Provide advice and advance warning on potential regulatory risks and proposing preventive or corrective measures accordingly


• Keep updated with FDA regulations and potential changes that will impact the business and advise the appropriate action plans


• Perform ad-hoc duties as assigned

Qualifications


• Bachelor's degree or Master's Degree in Pharmaceutical Science or Science


• Minimum 2 years of experience in cosmetics regulatory affairs


• Experience in cosmetics, beauty, skin care regulation is a plus


• Solid knowledge of Cosmetic Products Control in Thailand Guidelines and ASEAN Cosmetic Directive (ACD)


• Excellent time management and interpersonal skills


• Good command in English