Senior Regulatory Affairs Executive

JOB SUMMARY

Manage submission plan, prepare documents and execute all cosmetics, pharmaceuticals and medical devices regulatory activities in compliance with regulatory and legislative requirements to support timely and smooth launching of activities for marketing plan as well as sales of products.

KEY ACCOUNTABILITIES

1. Monitor and review the products' licenses, registrations and documentation requirements are in proper order to ensure the company meets the regulatory requirements especially the new regulations.
2. Perform due diligence on the new products, potentially to be registered and provide regulatory impact to internal and external stakeholders.
3. Ensure proper documentation of all regulatory applications and communications with principals and authorities.
4. Manages end to end process of new product registration/ variation applications/ notifications for pharmaceuticals/ medical devices/ cosmetics in the selected territories t...