Regulatory Assistant
5 days ago
Responsibilities
- Prepare and submit LTO applications (initial, renewal, or variation) through the FDA ePortal
- Compile and submit complete CPR dossiers in compliance with FDA AO and relevant regulations
- Coordinate with third-party laboratories for product testing (e.g., microbiological, physico-chemical)
- Monitor application status via FDA eServices and respond to FDA queries or deficiencies
- Maintain an updated compliance tracker for LTO and CPR expirations, renewals, and ongoing applications.
- Ensure that product labels, inserts, and promotional materials comply with FDA regulations
- Liaise with regulatory bodies such as BAI (for animal products), DA, or DOH as needed
- Assist in FDA inspections, audits, and document control for quality management
- Bachelor’s degree in Food Technology or related field
- At least 1 yr of hands-on experience in FDA product registration and LTO process
- Strong knowledge of FDA Circulars, AO and e-portal submission system
- Familiarity with product classification, risk categories and labeling standards
- Excellent documentation, communication, and organizational skills
- Certification in HACCP, GMP, Halal is an advantage
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