Regulatory Affairs Officer

- Documentation

• Monitoring and updating of distributor licenses, Marketing Authorization Certificate.

• Monitoring reports containing records of products with Batch Notification and Lot Release Certificate

- Coordinates with the concerned departments for the collection of data/information and preparation of the following reports. Monitors and maintains an up-to-date records of the same:

• Monitor and prepare CAPA Reports from Principal/Third party audits

• Conduct preliminary investigation and coordinate with principal to handle of Customer Complaints

• Monitor and follow up implementation of products changes relevant to regulatory requirements

• Conduct regular audit to Distributor warehouse to ensure compliance to good distribution practice is in place, e.g storage condition, documentation system, etc.    

• Conduct regular product sampling from outlet to ensure compliance packaging labeling and to anticipate complain relevant to product quality.

- For finished product came from principal non Kalbe group/non indo product: how to ensure QA products in the market.  

• Ensure compliance for product in the market inline with regulation as set by FDA/local regulatory authority
• Support marketing team in term of promotion and advertising approval, hospital tender requirement
• As company representative, have a good communicate and build relationship with Regulatory Authority
• Responsible pharmacist for product registration in KI respective countries