Job Purpose: (to be defined per function, no activities but targets)

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

Main Tasks: (6-8 activities which are important for the function)

Set up a good registration strategy to drive New products speed to marketMarket continuity of registered products through efficient maintenance and renewal of licenses and tender submissionsCompliance to quality and regulatory requirements defined by local authorities and S&N policiesManagement of post-market activities to ensure patient safety, product quality and regulatory complianceEstablishment 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 for Regulatory Affairs. Ensures the Company complies with current Local Health Authority regulations in TWMaintain 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 approvalsSupports the company in identifying and eliminating Regulatory risks.Optimize cross-functional support needs in the company, ensuring effective communication with the Medical, Marketing and Sales Teams.Other RAQA activities, including but not limit to local labelling, OTC pack, GDP, post-market activities, UDI, import permit.

Supplementary Tasks: (special activities)

Conduct review of promotional materialsProof reading or minor translations of English sections

Job Requirements: (from recruitment process)

3 years or above relevant experience (Less experience will also be considered)Fluent oral and written skills in EnglishStrategic thinking and planningEffective negotiation and influencingClear and actionable communicationAccurate sense of urgency, prioritization and delegationUpdated and comprehensive knowledge of local regulations, and ability to translate them into actionable strategiesGood problem solving skillsCan-do attitude

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