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Experience:

2 years required

Skills:

Quality Assurance, English

Job type:

Full-time

• 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.
• 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.