Regulatory Affairs and Quality Supervisor

Job content

Job Purpose:

Ensure product registrations, tender preparation, regulatory compliance, and product quality in the Taiwan and Hongkong region

Main Tasks:

• Set up a good registration strategy to drive New products speed to market
• Market continuity of registered products through efficient maintenance and renewal of licenses and tender submissions
• Compliance to quality and regulatory requirements defined by local authorities 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.
• Maintain good working relationship with competency authority in the region and seek to influence appropriately, with the aim of achieving optimal registrations with minimal delay.
• Participate in cross functional team activities from initial stages through securing government approvals
• 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 Medical, Marketing and Sales Teams.
• Supporting on reimbursement process to ensure timely market access
• Other RAQA activities, including but not limit to local labelling, OTC pack, GDP, post-market activities, UDI, import permit.
  

Supplementary Tasks:

• Conduct review of promotional materials
• Proof reading or minor translations of English sections
  
  

Job Requirements:

• Fluent oral and written skills in English
• Strategic thinking and planning
• Effective negotiation and influencing
• Clear and actionable communication
• Accurate sense of urgency, prioritization and delegation
• Updated and comprehensive knowledge of local regulations, and ability to translate them into actionable strategies
• Good problem solving skills
• Can-do attitude