The FDA Documents Specialist is responsible for managing the documentation and regulatory processes required for Thai FDA registration. This role acts as the key liaison between suppliers, internal teams, and regulatory bodies to ensure products meet compliance standards and are registered efficiently and accurately.
Key Roles and Responsibilities:
- Communicate with suppliers to collect required documentation for FDA registration and clearly explain Thai FDA regulations and requirements.
- Confirm product claims and ensure supporting documents are complete and accurate.
- Coordinate with the import services team to screen products with sensitive ingredients (e.g., DLD).
- Verify the validity of product documentation before submission for registration.
- Collaborate with the FDA team to ensure timely and accurate product registration.
- Arrange product samples for lab testing or required documents for nutritional labeling.
- Work with suppliers to obtain any additional documents requested by the FDA.
- Coordinate with the shipments team to manage the delivery of samples for testing or evaluation.
- Collect new supplier documentation and coordinate with the accounting team for supplier registration.
- Align with suppliers and the QA team to review and approve labels printed on packaging at the origin.
- Track and update the progress of product registrations to align with buyer priorities and timelines.
Qualification:
- Bachelor's degree in Food Science, Pharmacy, Business Administration, or a related field.
- At least 1–3 years of experience in FDA documentation, regulatory affairs, or import compliance (experience in food or consumer goods industry is a plus).
- Good understanding of Thai FDA regulations and product registration processes.
- Strong communication skills in both Thai and English.
- Proficiency in Microsoft Excel and document management tools.
- Detail-oriented, proactive, and well-organized.
- Ability to work at the Central Chaengwattana Office Tower.
