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Job type:

Full-time

• We're committed to bringing passion and customer focus to the business.
• Head of Regulatory Affairs - Beverage and Factory License
• Regulatory Expertise for beverages products and multiple factory license from authorities i.e. Ministry of Industry, Ministry of Energy, Ministry of Natural Resources and Environment, District Office in Bangkok, Local Provincial Department, etc to ensure product were launched on times and smooth operation and support business growthHead of Regulatory Affairs - Non-Beverage & Supplement
• Regulatory Expertise for personalcare, homecare, healthcare (modern medicine, traditional medicine, food supplement, herbal products) and confectionary products that are compliance with regulation and product license approved in accordance to the acceptable and alignment timely to support the business growth.
• IB Regulatory Affairs Champion
• Regulatory expertise for beverages and personal care products for International Business i.e. Myanmar, Vietnam, Laos, Cambodia, EU and US etc. by developing and implementing practical regulatory strategies to ensure full compliance to all applicable laws, rules, regulations and standards to get the properly license on time to supportive the business growth.
• If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!.

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.