Responsibility 

1. Regulatory Submissions: 

• Prepare, coordinate, and submit regulatory dossiers and applications to the Indonesian regulatory authorities (e.g., BPOM). 

• Track submission progress and proactively address any queries or requests from the authorities. 

• Provide timely updates, monthly reports, and KPI reports on submission status to the Regulatory Affairs Manager in Indonesia. 

1. Documentation and Database Management: 

• Compile, organize, and maintain comprehensive regulatory documentation, including source of product registration and approvals. 

• Ensure accurate and up-to-date regulatory information is kept in relevant databases and systems. 

1. Compliance Support: 

• Marketing claims: Maintain a current and accurate list of permitted and prohibited claims in accordance with local regulations. Review and ensure product claim compliance.  

• Label: Ensure that all product labels comply with Indonesian labeling regulations and requirements. 

• Inspection: Assist the Regulatory Affairs Manager in Indonesia during local regulatory inspections, including preparation and follow-up activities. 

1. Regulatory Monitoring:  

• Monitor new Indonesian regulations and guidelines relevant to the company's products. 

• Provide timely updates and summaries of regulatory changes to the Regulatory Affairs Manager and relevant stakeholders. 

• Assess the potential impact of new regulations on the company's products and operations. 

• Diploma/degree with science background.
• Preferable with 2-3 years of working experience in regulatory areas.
• Good in time management and able to work in a fast-paced work environment
• A good team player.