Regulatory Affairs Specialist

2 weeks ago

Manila, National Capital Region, Philippines OATSIDE Full time ₱900,000 - ₱1,200,000 per year

Responsibilities:

  • Prepare product specifications and related information upon request
  • Coordinate with internal and global regulatory team to ensure that the registration dossier meet the requirements of PH FDA and properly manage and resolve the issues.
  • Responsible for product submission in PH FDA e-submission system
  • Deal with PH FDA on any matters such as importing and exporting product licenses, manufacturing license and certificate of free sale
  • Support artwork and product claims reviews upon request
  • Others as assigned for regulatory affairs' activities

Qualifications:

  • Bachelor's degree in food science, Food Technology, Biotechnology, Biochemistry, Agricultural industry or related fields
  • Good command of spoken and written English
  • 3 – 5 years' experience in regulation or Food product registration
  • Able to work independent, travel to FDA, Understanding process to contact PH FDA

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