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FMCG & Retail
02 Feb 2023
Regulatory Affairs Manager (130K-140K)
Position
Regulatory Affairs Manager (130K-140K)
Our Client
A Global Leading FMCG Company
Location
Bangplee, Samutprakarn
Report to
Regulatory Affairs Director - SEA

Responsibilities:

  • Review, validate, and give suggestions in the area of Specialized Nutrition and Adult Nutrition composition & specifications, labeling, and packaging design have complied with local regulations, international regulations, and guidelines and policies framework
  • Use regulatory experiences and insights as input to support the Head of RA to formulate and execute regulatory strategies to secure registration of products (both recipe and label) with government authorities. 
  • Achieve the registration process to get FDA approval as planned and ensure all concerned documents are completed and ready to be submitted for FDA’s consideration i.e. Application form, GMP certificate, COA, COF, Product specification sheet, Certificate of the manufacturer, Import license, Label, Clinical study, etc. 
  • Solve problems that are from government agencies by giving and receiving recommendations to and from a relevant cross-functional team so that registration can be completed as per plan. 
  • Close monitoring and follow-up on product/label registrations to ensure it is as per the project timeline/plan. Communicate immediately to management and relevant cross-functional team member in the project team if the registration process is expected to delay, require more information, or may impact the product launch plan. 

Qualifications:

  • At least 8 years of experience in regulatory affairs in the nutrition business or food industry.
  • Master's Degree in Food Science/Nutrition or Dietetics and/or Pharmacy or relevant science field (preferably Master's degree).
  • Good knowledge and experience with Food laws and regulations in Thailand and Codex Standards/EU.
  • Problem-solving & detail-oriented with strong analytical thinking skills.
  • Good attitude/interpersonal skills and collaborative mindset.