Regulatory Documentation & Submissions:
- Prepare, compile, and submit regulatory documentation, including applications, dossiers, and technical files, to regulatory agencies (e.g., FDA, TISI, DLD) in a timely and compliant manner.
- Ensure timely and compliant submissions, and maintain a well-organized regulatory document database using appropriate software.
Regulatory Monitoring & Compliance:
- Track and analyze regulatory changes, assess their impact, and develop compliance strategies.
- Maintain accurate records and conduct internal audits to ensure ongoing adherence to regulations.
- Monitor changes in regulatory requirements and standards globally and assess their impact on company products and processes. Ensure ongoing compliance with all applicable regulations.
- Stay up to date with the latest developments in regulations, guidelines, and industry standards. Conduct regulatory intelligence to anticipate potential regulatory challenges and opportunities.
- Update new regulation or any changes which will impact the company.
Regulatory Authority Communication:
- Serve as the primary liaison with regulatory agencies, building strong relationships.
- Represent the company in agency interactions and respond efficiently to inquiries.
Process Enhancement:
- Identify and implement improvements to regulatory processes for greater efficiency.
- Apply best practices and utilize relevant software and project management tools.
Cross-functional Collaboration:
- Work closely with Sourcing, Purchasing, Compliance and Logistic teams to provide regulatory guidance and support during product development and post-marketing activities.
- Support regulatory inspections, audits, and external agency interactions. Prepare responses to regulatory agency questions, deficiencies, or findings.
- Ensure all regulatory documentation is accurate, complete, and stored in accordance with regulatory requirements and company policies.
- Advise on regulations related to food products, food quality standards, and importation, and update regulations as needed.
- Any other ad-hoc duties assigned by superior.
Assigned Product:
• Chemicals
• Foods
• Fragrance