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