Regulatory Approval Representative 1

仕事内容

• Market continuity of registered products through efficient maintenance and renewal of licenses and tender submissions
• Compliance to quality and regulatory requirements defined by TFDA and S&N policies
• Management of post-market activities to ensure patient safety, product quality and regulatory compliance
• Establishment and management of relevant quality processes and practices to both meet competent authority and company expectations.
• Ensures compliance with current and new regulations and Guidelines within Taiwan and HK for Regulatory Affairs. Ensures the Company complies with current Local Health Authority regulations in TW and HK.
• Supports the company in identifying and eliminating Regulatory risks.
• Optimize cross-functional support needs in the company, ensuring effective communication between direct reports and with the commercial and Marketing Teams.
• Supporting on documentation related on reimbursement process to ensure timely market access
• Key RAQA activities for regulation change, including but not limit to GDP, UDI ,local labelling, OTC pack and etc.