Responsibilities

• Committed to respect specific rules to comply with the WHO Code of Breast Milk Substitutes and any related regulations applying locally
• CBUs: Being accountable and responsible for overall WISE (Working In Safe Environmental), RiGHT Way, FoQual (Focus on Quality), 1000 days and Nature as part of way of working for Dumex employee.
• Responsible for the local and international regulations and requirements for milk powder.
• Ensure that all products are complied with the relevant regulations and notifications of Thai FDA
• Support for all products registration (new product and amendment) and all of FDA licenses, etc
• Support for sample analysis process, nutrition calculation, documentations preparation, etc
• Coordinate with R&D and the external laboratories for lab analysis process
• Check the accuracy of sample code and the target (figure and unit) from R&I before sending them out to the external laboratories i.e. TISTR, SGS, CLF, etc
• Prepare the pack labeling and all concerned documents to be completed and ready to be submitted for FDA's consideration i.e. Application form, GMP certificate, COA, COO, Product specification sheet, Certificate of manufacturer, Import license, Label, Clinical study, etc.
• Function as the supporter to contact with FDA and all concerned government organizations for all matters concerning the product registrations (new product and amendment), Processing license, Import license, Product licenses and Advertisement licenses, etc
• Being a representative to attend the external meeting with all industries and all concerned government organizations which related to product registration and compliance
• Maintain the good relationships with FDA and all concerned government organizations.

Qualifications

• Bachelor's or Master Degree in Nutrition or Food Science or related fields.
• 2 years in Regulatory Affairs role from food industry or pharmaceutical industry
• Good knowledge of Nutrition Science and Food Science
• Background in contacting FDA will be an advantage
• Knowledge on food regulatory
• Good problem-solving skills and interpersonal skills
• Good team player
• Good communication & Negotiation skills
• Good command of English
• Proficiency in Microsoft Office programs