Regulatory Affairs Officer/ Assistant
About this position
Responsibilities
• Regulatory Strategy Development: Develop and implement regulatory strategies for product development, approval, and lifecycle management to ensure compliance with local, regional, and international regulations.
• Regulatory Submissions: Prepare, compile, and submit regulatory documentation, including applications, dossiers, and technical files, to regulatory agencies (e.g., FDA, DOF, DLD) in a timely and compliant manner.
• Compliance Monitoring: Monitor changes in regulatory requirements and standards globally and assess their impact on company products and processes. Ensure ongoing compliance with all applicable regulations.
• Cross-functional Collaboration: Work closely with Sourcing, Purchasing, Quality, Manufacturing, and Marketing teams to provide regulatory guidance and support during product development, labeling, advertising, and post-marketing activities.
• Regulatory Intelligence: Stay up to date with the latest developments in regulations, guidelines, and industry standards. Conduct regulatory intelligence to anticipate potential regulatory challenges and opportunities.
• Regulatory Affairs Leadership: Provide leadership and mentorship to junior regulatory staff, fostering a culture of compliance and continuous improvement.
• Inspections and Audits: Support regulatory inspections, audits, and external agency interactions. Prepare responses to regulatory agency questions, deficiencies, or findings.
• Documentation Management: Ensure all regulatory documentation is accurate, complete, and stored in accordance with regulatory requirements and company policies.
Requirements
• Bachelor's degree in Food Science or related fields.
• 3-5 years of experience in the FDA registration process, Food Quality and Food Safety system.
• Have experience or knowledge about the Thai FDA and Quality System (TH regulations, GHPs/HACCP, ISO22000, BRC etc.)
• Knowledge of the FDA registration process and/or DCC (Document Control Clerk) for any applicable QMS is a must.
• Good command in English & Thai both written and spoken.