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Regulatory Affairs Specialist

Max Biocare

Mô tả công việc Prepare quality and regulatory documentation for timely submission to regulatory authorities in countries including, but not limited to, Australia, Vietnam, Singapore, Malaysia, Indonesia, and Thailand for products including cosmetics, skincare, personal care and supplements, with some support for other regulated products where required. Monitor progress and conduct suitable follow up to ensure registration is granted in time for product launches. Prepare and maintain Cosmetics PIFs (Product Information Files) and manage product data in Cosmetri, including but not limited to creating and updating product formulations; new raw materials; uploading and maintaining raw material documents (e.g. specs, COA, SDS, allergen documents); exporting formulation data to support internal teams. Participate in artwork and labelling lifecycle coordination to ensure compliance with current regulatory Australian and export market requirements, including checking artworks for accuracy and compliance before print. Prepare and/or review QMS documentation including SOPs, specifications, and batch manufacturing/packaging records. Collate quality system information/data for effective trending purposes. Provide QA/regulatory support with new product development. Participate in investigation of customer complaints. Assist in the coordination of regulatory affairs/quality assurance projects, as assigned. Training and supervising junior Regulatory team members (for the right candidate).

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Company Information

TMI Joint Stock Company
Tax ID: 0109904638
21st Floor, Viwaseen Tower, 48 To Huu, Trung Van, Nam Tu Liem, Hanoi