Job Description:
- Establish the regulatory database of global/local and customer regulations in cosmetic, homecare and medical devices.
- Assessment all information of products, formulation, ingredients, packaging, labelling are designed according to essential regulatory requirement and make decision already comply or not.
- Update the regulatory database to be present and accurately.
- Management and training all related persons use the database correctly and update to present.
- Responsible for Product Information Files of New products to create in Product Vision and prompt submit to FDA authorities once request upon.
- Providing advice and advance warning on potential regulatory risks and proposing preventive or corrective measures accordingly.
- Develop and write a broad range of documents and SOPs
- Maintaining regulatory files, in accordance with ISO standard.
- Support all regulatory issues relevant from customer enquiries.
- Supporting I&D team for formulation development, provide suggestion and testing requirement for new product.
- Review claim substantiation, claim wording, evidence by coordinate with formulators and BD or Customer (if require)
- Review all certificates and the production license expiry date and propose the renewal process: Production license of Cosmetics, Home care and Medical Devices.GMP of Cosmetics and Homecare.Notification of Cosmetic products.Registration of Homecare products,Halal Assurance System and Product Halal Certificates.
Requirements:
- Bachelor degree or above in Chemistry or Pharmacist
- Minimum of 5 years experience of Regulatory experience
- Have experience in Cosmetic, Homecare, Medical Devices and Halal regulation and rule