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26 Feb 2020
Job Opportunity : RA Manager (100K)
Position
RA Manager (100K)
Our Client
A Leading International Consumer Goods Company
Location
Bangkok
Report to
Head of RA Manager

Responsibilities :

  • Committed to respect specific rules to comply with the WHO Code of Breast Milk Substitutes and any related regulations applying locally
  • Responsible for IFFO GUM and innovation products registration (new product and amendment) i.e. sample analysis process, documentations preparation, nutritional compliance etc
  • Ensure that IFFO GUM and innovation products are complied with the relevant local regulations, international standards, and Internal guideline
  • Contribute regulation information to support new product development
  • Influence local regulation according to scientific information and business needed
  • Maintain and develop the good relationships with FDA/DLD and all concerned government organizations
  • Being a representative to attend the external meeting with all industries and all concerned government organizations which related to product registration and compliance
  • Review, validate, give suggestion on IFFO GUM and Innovation product composition & specifications, labeling and packaging design are compiled under local regulation, international regulation, and global’s guidelines and policies framework
  • Achieve the registration process to get FDA approval as plan 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 manufacturer, Import license, Label, Clinical study, etc
  • Contribute to innovation projects by bringing regulatory expertise &solutions to development project team
  • Monitor and/or contribute to implement evolution in legislation or new legislation, communicate and train to concerned internal stakeholders
  • Immediately inform to all concerned persons if there are the important issues that may impact to products or launch plan or company such as crisis, FDA’s consideration, or any changes that may affect to company
  • Support to Supply chain and Shipping agencies, QFS , R&I and Financial & Accounting regarding the registered documents or food regulatory issue for their further process

Qualifications : 

  • Bachelor’s degree and Master’s degree of Nutrition or Food Science or related fields
  • Communication skill / Negotiation skill
  • Good at English (listening, speaking, reading and writing)
  • Product law & regulations
  • Consumer, advertising & promo Law & Regulatory
  • Develop cross-functional effectiveness
  • Manage several projects in parallel