Regulatory Affairs Executive

Job responsibilities

Responsibility

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.

 

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.

 

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.

 

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.

Profile

Qualifications

• 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.